<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458259</url>
  </required_header>
  <id_info>
    <org_study_id>C4201002</org_study_id>
    <secondary_id>ARRAY-067-102</secondary_id>
    <secondary_id>2021-004270-59</secondary_id>
    <nct_id>NCT04458259</nct_id>
  </id_info>
  <brief_title>Study of PF-07265807 in Participants With Metastatic Solid Tumors.</brief_title>
  <official_title>A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF 07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as&#xD;
      Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Anticipated">February 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Dose escalation and expansion</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)</measure>
    <time_frame>Baseline through day 21 or 42</time_frame>
    <description>DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parts 1, 2, and 3: Number of participants with laboratory abnormalities</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Laboratory abnormalities as characterized by type, frequency, severity, and timing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 4: Overall Response Rate (ORR)</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Response will be evaluable via radiographical tumor assessment by RECIST v1.1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 4, Cohort 4: Complete Response (CR)</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Response will be evaluated via radiographical tumor assessment by RECIST v1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>Single dose (Cmax) and multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose</time_frame>
    <description>Multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of axitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>Single dose (Tmax) and multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Single dose (Tmax) pharmacokinetic parameters of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose</time_frame>
    <description>Multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of axitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>Single dose (AUClast) pharmacokinetic parameters of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Single dose (AUClast) pharmacokinetic parameters of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose</time_frame>
    <description>Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of axitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>As data permits, single dose (t1/2) pharmacokinetic parameters of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>As data permits, single dose (AUCinf) pharmacokinetic parameters of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>As data permits, single dose (AUCinf) pharmacokinetic parameters of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>As data permits, single dose (CL/F) and multiple dose pharmacokinetic parameters of PF-07265807</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose</time_frame>
    <description>As data permits, single dose (Vz/F) and multiple dose (Vss/F) pharmacokinetic parameters of PF-07265807</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 1, 2, and 3: ORR</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Response will be evaluable via radiographical tumor assessment by RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 4: Number of participants with treatment emergent AEs</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 4: Number of participants with laboratory abnormalities</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Laboratory abnormalities as characterized by type, frequency, severity, and timing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose</time_frame>
    <description>Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose</time_frame>
    <description>Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose</time_frame>
    <description>Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib</measure>
    <time_frame>Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose</time_frame>
    <description>Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Incidence and titer of anti-sasanlimab ADA response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Response will be evaluable via radiographical tumor assessment by RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Response will be evaluable via radiographical tumor assessment by RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Baseline through approximately 2 years</time_frame>
    <description>Response will be evaluable via radiographical tumor assessment by RECIST v1.1</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Neoplasm Metastasis</condition>
  <arm_group>
    <arm_group_label>Monotherapy Dose Escalation: Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Monotherapy dose escalation of PF-07265807 in participants with select tumor types.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Doublet Dose Escalation: Part 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triplet Dose Escalation: Part 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Phase: Part 4, Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PF-07265807 monotherapy in participants with METex14 mutant NSCLC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Phase: Part 4, Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PF-07265807 with sasanlimab in participants with MSS CRC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Phase: Part 4, Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expansion Phase: Part 4, Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PF-07265807 with sasanlimab plus axitinib in participants with RCC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-07265807</intervention_name>
    <description>Given 2 weeks on/1 week off</description>
    <arm_group_label>Doublet Dose Escalation: Part 2</arm_group_label>
    <arm_group_label>Expansion Phase: Part 4, Cohort 1</arm_group_label>
    <arm_group_label>Expansion Phase: Part 4, Cohort 2</arm_group_label>
    <arm_group_label>Expansion Phase: Part 4, Cohort 3</arm_group_label>
    <arm_group_label>Expansion Phase: Part 4, Cohort 4</arm_group_label>
    <arm_group_label>Monotherapy Dose Escalation: Part 1</arm_group_label>
    <arm_group_label>Triplet Dose Escalation: Part 3</arm_group_label>
    <other_name>ARRY-067</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sasanlimab</intervention_name>
    <description>Given SC Q3W</description>
    <arm_group_label>Doublet Dose Escalation: Part 2</arm_group_label>
    <arm_group_label>Expansion Phase: Part 4, Cohort 2</arm_group_label>
    <arm_group_label>Expansion Phase: Part 4, Cohort 3</arm_group_label>
    <arm_group_label>Expansion Phase: Part 4, Cohort 4</arm_group_label>
    <arm_group_label>Triplet Dose Escalation: Part 3</arm_group_label>
    <other_name>PF-06801591; RN-888</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Axitinib</intervention_name>
    <description>Dosed per package label starting with 5 mg PO BID</description>
    <arm_group_label>Expansion Phase: Part 4, Cohort 4</arm_group_label>
    <arm_group_label>Triplet Dose Escalation: Part 3</arm_group_label>
    <other_name>AG-013736; Inlyta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), not&#xD;
             previously irradiated, as defined by RECIST 1.1&#xD;
&#xD;
          -  ECOG Performance Status 0 or 1, 2 with approval&#xD;
&#xD;
          -  Adequate Bone Marrow Function&#xD;
&#xD;
          -  Adequate Renal Function&#xD;
&#xD;
          -  Adequate Liver Function&#xD;
&#xD;
          -  Resolved acute effects of any prior therapy&#xD;
&#xD;
          -  Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some&#xD;
             participants will require mandatory pre- and on-treatment biopsy is part of the&#xD;
             biomarker cohort).&#xD;
&#xD;
          -  Life expectancy of at least 3 months.&#xD;
&#xD;
          -  Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment&#xD;
             for selected solid tumors.&#xD;
&#xD;
          -  Part 3: Participants with advanced/metastatic RCC with a clear cell component and&#xD;
             progressed with no standard therapy available.&#xD;
&#xD;
          -  Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and&#xD;
             progressed on at least 1 prior therapy.&#xD;
&#xD;
          -  Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with&#xD;
             no satisfactory alternative treatment available, but has not received prior treatment&#xD;
             with an anti-PD-(L)1 therapy.&#xD;
&#xD;
          -  Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is&#xD;
             PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy&#xD;
             regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.&#xD;
&#xD;
          -  Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with&#xD;
             IMDC intermediate or poor risk that have not received any prior systemic therapy for&#xD;
             metastatic disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known active uncontrolled or symptomatic CNS metastases.&#xD;
&#xD;
          -  Any other active malignancy within 2 years prior to enrollment.&#xD;
&#xD;
          -  Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer&#xD;
             therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies&#xD;
             or investigational drug(s) taken on another study) prior to study entry.&#xD;
&#xD;
          -  Active or history of autoimmune disease requiring &gt;10mg/day prednisone or other&#xD;
             concurrent immunosuppressive therapy.&#xD;
&#xD;
          -  Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as&#xD;
             defined in protocol.&#xD;
&#xD;
          -  Retinal or other serious ophthalmic disorders as defined in protocol.&#xD;
&#xD;
          -  Clinically significant cardiac disease as defined in protocol.&#xD;
&#xD;
          -  Uncontrolled HTN that cannot be controlled by medications.&#xD;
&#xD;
          -  Inability to consume or absorb study drug.&#xD;
&#xD;
          -  Known or suspected hypersensitivity to PF-07265807.&#xD;
&#xD;
          -  Prohibited concomitant medications as defined in protocol.&#xD;
&#xD;
          -  Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric&#xD;
             resection or lap band surgery affecting absorption.&#xD;
&#xD;
          -  Active bleeding disorder.&#xD;
&#xD;
          -  Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.&#xD;
&#xD;
          -  Experienced &gt;= G3 treatment-related irAE with prior PD-(L)1 agent.&#xD;
&#xD;
          -  Prior treatment with selective AXL/MERTK inhibitors&#xD;
&#xD;
        For participants receiving sasanlimab:&#xD;
&#xD;
        - Known history of non-infectious pneumonitis that required steroid treatment or current&#xD;
        pneumonitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Eye Clinic</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Irvine Health</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868-3201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868-3201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Irvine Health</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCI Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCI Medical Center- Outpatient Pharmacy</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCI/Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical &amp; Translational Science Institute</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Helen Diller Family Comprehensive Cancer Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Investigational Drugs Pharmacy</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Lions Eye Institute (RMLEI)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network, Inc.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network, Inc.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network Cancer Center North</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network Investigational Drug Services</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network, Inc.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network, Inc.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute - Chestnut Hill</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Eye Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas M. D. Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HPS Pharmacies Darlinghurst</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University</name>
      <address>
        <city>Macquarie University</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences-Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Quebec-Universite Laval - Hotel Dieu de Quebec</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1R 2J6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Province Tumor Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria delle Marche</name>
      <address>
        <city>Ancona</city>
        <state>AN</state>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS San Gerardo dei Tintori</name>
      <address>
        <city>Monza</city>
        <state>Lombardia</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore</name>
      <address>
        <city>Roma</city>
        <state>Rome</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia IRCCS</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chayagasaka Eye Clinic</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-0092</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Nagoya, Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Seoul-teukbyeolsi [seoul]</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Songpa-gu</city>
        <state>Seoul-teukbyeolsi [seoul]</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>China</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C4201002</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TAMK (TAM kinase)</keyword>
  <keyword>MER (mer proto-oncogene)</keyword>
  <keyword>MERTK (mer proto-oncogene tyrosine kinase)</keyword>
  <keyword>AXL (AXL receptor tyrosine kinase)</keyword>
  <keyword>AXL/MER</keyword>
  <keyword>Selective kinase inhibitor</keyword>
  <keyword>PD-1 (programmed cell death protein 1)</keyword>
  <keyword>PD-L1 (programmed cell death ligand 1)</keyword>
  <keyword>Immune modulator</keyword>
  <keyword>Advanced Cancer</keyword>
  <keyword>Metastatic Cancer</keyword>
  <keyword>Solid Tumor Cancer</keyword>
  <keyword>Metastatic Solid Tumor</keyword>
  <keyword>Cervical Cancer</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Esophageal Cancer</keyword>
  <keyword>Endometrial Cancer</keyword>
  <keyword>Hepatocellular carcinoma (HCC)</keyword>
  <keyword>Melanoma</keyword>
  <keyword>Merkel Cell Carcinoma</keyword>
  <keyword>High levels of MicroSatellite Instability deficient MisMatch Repair (MSI-H-dMMR) tumor</keyword>
  <keyword>Non-small cell lung cancer (NSCLC)</keyword>
  <keyword>Small cell lung cancer (SCLC)</keyword>
  <keyword>Renal cell carcinoma (RCC)</keyword>
  <keyword>Urothelial carcinoma</keyword>
  <keyword>Colorectal cancer (CRC)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Axitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458259
org study id: C4201002
secondary id: ARRAY-067-102
secondary id: 2021-004270-59
nct id: NCT04458259
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as
      Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Dose escalation and expansion
primary purpose: Treatment
masking: None (Open Label)
measure: Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
time frame: Baseline through day 21 or 42
description: DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
measure: Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
time frame: Baseline through approximately 2 years
description: AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
measure: Parts 1, 2, and 3: Number of participants with laboratory abnormalities
time frame: Baseline through approximately 2 years
description: Laboratory abnormalities as characterized by type, frequency, severity, and timing.
measure: Part 4: Overall Response Rate (ORR)
time frame: Baseline through approximately 2 years
description: Response will be evaluable via radiographical tumor assessment by RECIST v1.1
measure: Part 4, Cohort 4: Complete Response (CR)
time frame: Baseline through approximately 2 years
description: Response will be evaluated via radiographical tumor assessment by RECIST v1.1
measure: Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: Single dose (Cmax) and multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of PF-07265807 and its metabolite
measure: Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
time frame: Through study completion, an average of 1 year
description: Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab
measure: Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
description: Multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of axitinib
measure: Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: Single dose (Tmax) and multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
measure: Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
time frame: Through study completion, an average of 1 year
description: Single dose (Tmax) pharmacokinetic parameters of sasanlimab
measure: Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
description: Multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of axitinib
measure: Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: Single dose (AUClast) pharmacokinetic parameters of PF-07265807 and its metabolite
measure: Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
time frame: Through study completion, an average of 1 year
description: Single dose (AUClast) pharmacokinetic parameters of sasanlimab
measure: Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
measure: Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
description: Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of axitinib
measure: Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: As data permits, single dose (t1/2) pharmacokinetic parameters of PF-07265807 and its metabolite
measure: Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
time frame: Through study completion, an average of 1 year
description: As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab
measure: Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: As data permits, single dose (AUCinf) pharmacokinetic parameters of PF-07265807 and its metabolite
measure: Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
time frame: Through study completion, an average of 1 year
description: As data permits, single dose (AUCinf) pharmacokinetic parameters of sasanlimab
measure: Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: As data permits, single dose (CL/F) and multiple dose pharmacokinetic parameters of PF-07265807
measure: Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
time frame: Through study completion, an average of 1 year
description: As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab
measure: Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
description: As data permits, single dose (Vz/F) and multiple dose (Vss/F) pharmacokinetic parameters of PF-07265807
measure: Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
time frame: Through study completion, an average of 1 year
description: As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab
measure: Parts 1, 2, and 3: ORR
time frame: Baseline through approximately 2 years
description: Response will be evaluable via radiographical tumor assessment by RECIST v1.1
measure: Part 4: Number of participants with treatment emergent AEs
time frame: Baseline through approximately 2 years
description: AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
measure: Part 4: Number of participants with laboratory abnormalities
time frame: Baseline through approximately 2 years
description: Laboratory abnormalities as characterized by type, frequency, severity, and timing
measure: Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
description: Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
measure: Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
time frame: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
description: Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
measure: Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
time frame: Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose
description: Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab
measure: Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
time frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
description: Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib
measure: Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
time frame: Through study completion, an average of 1 year
description: Incidence and titer of anti-sasanlimab ADA response
measure: Duration of Response
time frame: Baseline through approximately 2 years
description: Response will be evaluable via radiographical tumor assessment by RECIST v1.1
measure: Disease Control Rate
time frame: Baseline through approximately 2 years
description: Response will be evaluable via radiographical tumor assessment by RECIST v1.1
measure: Progression Free Survival
time frame: Baseline through approximately 2 years
description: Response will be evaluable via radiographical tumor assessment by RECIST v1.1
arm group label: Monotherapy Dose Escalation: Part 1
arm group type: Experimental
description: Monotherapy dose escalation of PF-07265807 in participants with select tumor types.
arm group label: Doublet Dose Escalation: Part 2
arm group type: Experimental
description: Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.
arm group label: Triplet Dose Escalation: Part 3
arm group type: Experimental
description: Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.
arm group label: Expansion Phase: Part 4, Cohort 1
arm group type: Experimental
description: PF-07265807 monotherapy in participants with METex14 mutant NSCLC.
arm group label: Expansion Phase: Part 4, Cohort 2
arm group type: Experimental
description: PF-07265807 with sasanlimab in participants with MSS CRC
arm group label: Expansion Phase: Part 4, Cohort 3
arm group type: Experimental
description: PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ
arm group label: Expansion Phase: Part 4, Cohort 4
arm group type: Experimental
description: PF-07265807 with sasanlimab plus axitinib in participants with RCC
intervention type: Drug
intervention name: PF-07265807
description: Given 2 weeks on/1 week off
arm group label: Doublet Dose Escalation: Part 2
arm group label: Expansion Phase: Part 4, Cohort 1
arm group label: Expansion Phase: Part 4, Cohort 2
arm group label: Expansion Phase: Part 4, Cohort 3
arm group label: Expansion Phase: Part 4, Cohort 4
arm group label: Monotherapy Dose Escalation: Part 1
arm group label: Triplet Dose Escalation: Part 3
other name: ARRY-067
intervention type: Drug
intervention name: Sasanlimab
description: Given SC Q3W
arm group label: Doublet Dose Escalation: Part 2
arm group label: Expansion Phase: Part 4, Cohort 2
arm group label: Expansion Phase: Part 4, Cohort 3
arm group label: Expansion Phase: Part 4, Cohort 4
arm group label: Triplet Dose Escalation: Part 3
other name: PF-06801591; RN-888
intervention type: Drug
intervention name: Axitinib
description: Dosed per package label starting with 5 mg PO BID
arm group label: Expansion Phase: Part 4, Cohort 4
arm group label: Triplet Dose Escalation: Part 3
other name: AG-013736; Inlyta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: China
country: Italy
country: Japan
country: Korea, Republic of
country: Spain
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C4201002
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Axitinib
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.