<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/NCT03811652</url>
  </required_header>
  <id_info>
    <org_study_id>D8540C00002</org_study_id>
    <nct_id>NCT03811652</nct_id>
  </id_info>
  <brief_title>A Multiple Ascending Dose Study of MEDI7247 in Advanced or Metastatic Solid Tumors</brief_title>
  <official_title>A Phase 1/1b Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI7247 in Patients With Advanced or Metastatic Disease in Selected Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess safety and tolerability, describe the dose-limiting toxicities, assess the&#xD;
      preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest&#xD;
      protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and&#xD;
      a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or&#xD;
      metastatic solid tumor malignancies that have received at least 1 prior line of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">December 10, 2019</completion_date>
  <primary_completion_date type="Actual">December 10, 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Adverse Events</measure>
    <time_frame>From time of informed consent through 90 days post end of treatment</time_frame>
    <description>To assess the occurrence of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of Serious Adverse Events</measure>
    <time_frame>From time of informed consent through 90 days post end of treatment</time_frame>
    <description>To assess the occurrence of serious adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of Dose Limiting Toxicities</measure>
    <time_frame>During the evaluation period of 21 days post first dose</time_frame>
    <description>To assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with changes in laboratory parameters from baseline</measure>
    <time_frame>From time of informed consent through 90 days post end of treatment</time_frame>
    <description>To assess serum chemistry, hematology, urinalysis and coagulation parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with changes in vital signs parameters from baseline</measure>
    <time_frame>from time of informed consent through 21 days post last dose</time_frame>
    <description>to assess changes in vital signs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with changes in electrocardiogram results from baseline</measure>
    <time_frame>from time of informed consent through 21 days post last dose</time_frame>
    <description>to assess changes in ECG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients with changes in laboratory parameters from baseline</measure>
    <time_frame>from time of informed consent through 90 days post end of treatment</time_frame>
    <description>to assess changes in serum chemistry, hematology, urinalysis, and coagulation parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MEDI7247 maximum observed concentration (Cmax)</measure>
    <time_frame>From first dose through 90 days post end of treatment</time_frame>
    <description>To characterize MEDI7247 single agent Pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI7247 terminal half life (t1/2)</measure>
    <time_frame>From first dose through 90 days post end of treatment</time_frame>
    <description>To characterize single agent MEDI7247 pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI7247 area under the concentration/time curve (AUC)</measure>
    <time_frame>from first dose through 90 days post end of treatment</time_frame>
    <description>To characterize single agent MEDI7247 pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI7247 clearance</measure>
    <time_frame>from first dose through 90 days post end of treatment</time_frame>
    <description>to characterize the single agent MEDI7247 pharmacokinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects who develop anti-drug antibodies</measure>
    <time_frame>first dose through 90 days post end of treatment</time_frame>
    <description>To characterize MEDI7247 immunogenicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response</measure>
    <time_frame>From time of informed consent and up to 90 days post end of treatment</time_frame>
    <description>To assess antitumor activity of MEDI7247</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>From time of informed consent and up to 2 years after last subject in</time_frame>
    <description>To assess antitumor activity of MEDI7247</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR)</measure>
    <time_frame>From time of informed consent and up to 90 days post end of treatment</time_frame>
    <description>To assess antitumor activity of MEDI7247</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR)</measure>
    <time_frame>From time of informed consent and up to 2 years after last subject in</time_frame>
    <description>To assess antitumor activity of MEDI7247</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From time of informed consent and up to 2 years after last subject in</time_frame>
    <description>To assess the antitumor activity of MEDI7247</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control (DC)</measure>
    <time_frame>From time of informed consent and up to 2 years after last subject in</time_frame>
    <description>To assess antitumor activity of MEDI7247</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From time of informed consent and up to 2 years after last subject in</time_frame>
    <description>To assess antitumor activity of MEDI7247</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Non Small Cell Lung Cancer Squamous (NSCLC-Sq)</condition>
  <condition>Head and Neck Squamous Cell Carcinoma (HNSCC)</condition>
  <condition>Small Cell Lung Cancer (SCLC)</condition>
  <condition>Pancreatic Ductal Adenocarcinoma (PDAC)</condition>
  <condition>Colorectal Cancer (CRC)</condition>
  <condition>Metastatic Castration-resistant Prostate Cancer (mCRPC)</condition>
  <arm_group>
    <arm_group_label>NSCLC-Sq/HNSCC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with advanced or metastatic NSCLC-Sq or HNSCC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen (platinum-based for HNSCC). PDL-1 positive patients should have received previous PD-1 or PD-L1 inhibitor where available.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Small Cell Lung Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with metastatic adenocarcinoma of the colon or rectum who have received and have progressed, or have documented intolerance, on prior thymidylate synthase inhibitor (eg, 5-fluorouracil (5-FU), capecitabine, raltitrexed, tegafur-uracil (UFT), irinotecan, and oxaliplatin for metastatic disease. If patients progress within 6 months of their last dose of adjuvant therapy this should be considered as a line of therapy in the metastatic setting. Patients with known RAS wildtype tumors must have received and progressed, or have documented intolerance, on anti-EGFR antibody. Patients with microsatellite instability-high or deficient mismatch repair tumors, must have received and progressed, or have documented intolerance on a PD-1 inhibitor, or PD-1 inhibitor plus cytotoxic T-lymphocyte antigen-4 inhibitor treatment where available.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancreatic Ductal Adenocarcinoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with unresectable, locally advanced or metastatic PDAC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior line of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metastatic Castration-Resistant Prostate Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other advanced/metastatic target expressing solid tumors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with advanced or metastatic solid tumors not defined by other treatment arms who have positive expression of the protein target and have exhausted all approved therapies</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDI7247</intervention_name>
    <description>Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule</description>
    <arm_group_label>Colorectal Cancer</arm_group_label>
    <arm_group_label>Metastatic Castration-Resistant Prostate Cancer</arm_group_label>
    <arm_group_label>NSCLC-Sq/HNSCC</arm_group_label>
    <arm_group_label>Other advanced/metastatic target expressing solid tumors</arm_group_label>
    <arm_group_label>Pancreatic Ductal Adenocarcinoma</arm_group_label>
    <arm_group_label>Small Cell Lung Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed diagnosis of advanced or metastatic select solid tumors and either&#xD;
             progression on or documented intolerance to standard therapies&#xD;
&#xD;
          2. Age ≥ 18 years at the time of screening.&#xD;
&#xD;
          3. Written informed consent and any locally required authorization&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1&#xD;
&#xD;
          5. At least 1 measurable target lesion by CT or MRI per RECIST Version 1.1 (excluding&#xD;
             mCRPC)&#xD;
&#xD;
          6. Adequate Liver Function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase&#xD;
             (ALT) ≤ 2.5 × ULN (upper limit normal), Albumin &gt; 3 g/dL, and serum total bilirubin&#xD;
             (TBL) ≤ 1.5 × ULN; (unless bilirubin rise is due to Gilbert's syndrome, hepatic&#xD;
             metastases or of non-hepatic origin, in which case TBL ≤ 3 × ULN is allowed)&#xD;
&#xD;
          7. Creatinine Clearance (CrCL) ≥ 40 mL/min&#xD;
&#xD;
          8. Adequate Hematopoesis: Absolute Neutrophil Count (ANC) ≥ 1,500/μL, Platelets ≥&#xD;
             100,000/μL, and Hgb ≥ 9 g/dL unassisted by transfusion or growth factor within 14 days&#xD;
             of screening&#xD;
&#xD;
          9. Provision of archival or fresh tumor tissue at screening&#xD;
&#xD;
         10. Female patients of childbearing potential who are sexually active with a nonsterilized&#xD;
             male partner must use at least one highly effective method of contraception, and must&#xD;
             agree to continue using such precautions for 90 days after the last dose of&#xD;
             investigational product.&#xD;
&#xD;
         11. Nonsterilized male patients who are sexually active with a female partner of&#xD;
             childbearing potential must use a male condom plus spermicide from 7 days&#xD;
             post-screening and for 90 days after receipt of the last dose of investigational&#xD;
             product.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active central nervous system (CNS) metastases, unless adequately treated and patients&#xD;
             have neurologically returned to baseline (except for residual signs or symptoms&#xD;
             related to the CNS treatment) and prednisolone 10 mg or less for more than 2 weeks&#xD;
             prior to enrollment. For SCLC, a brain MRI scan that was conducted ≤ 28 days from Day&#xD;
             1 is required.&#xD;
&#xD;
          2. Residual toxicity from prior anticancer therapy not resolved to NCI CTCAE v4.03 Grade&#xD;
             1, with the exception of alopecia/vitiligo at the time of first dose of&#xD;
             investigational product. For patients previously receiving immunotherapy, toxicities&#xD;
             that are unlikely to recover to Grade 1.&#xD;
&#xD;
          3. Royal Marsden Hospital (RMH) prognostic score 2 and 3 at baseline.&#xD;
&#xD;
          4. Treatment with anticancer therapy including chemotherapy, radiation therapy,&#xD;
             immunotherapy, biologic, or any investigational therapy within 21 days, or prior&#xD;
             palliative radiotherapy within 2 weeks of the first dose of investigational product.&#xD;
&#xD;
        5 Prior treatment with other Pyrrolobenzodiazepine-Antibody Drug Conjugates.&#xD;
&#xD;
        6 History of previous malignancies (except for locally curable cancers) unless a complete&#xD;
        remission was achieved at least 3 years prior to study entry AND no additional therapy is&#xD;
        required during the study period (except adjuvant hormonal therapy and bisphosphonate).&#xD;
&#xD;
        7. Failure to recover from major surgery or significant traumatic injury within 21 days of&#xD;
        first dose of study treatment.&#xD;
&#xD;
        8 History of hepatic sinusoidal obstruction syndrome, also called veno-occlusive disease 9.&#xD;
        History of capillary leak syndrome. 10 Blood transfusion within 14 days of study entry&#xD;
        except when needed for disease related anemia.&#xD;
&#xD;
        11. New York Heart Association classes III-IV congestive heart failure or serious cardiac&#xD;
        arrhythmia requiring treatment, history of myocardial infarction, unstable angina, vascular&#xD;
        stent, or coronary artery bypass graft within 6 months of the first dose of investigational&#xD;
        product. 12. Active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or&#xD;
        hepatitis C virus (HCV) infections at the time of screening.&#xD;
&#xD;
        13. Current severe active systemic disease including active concurrent malignancy 14.&#xD;
        Pregnancy and/or breastfeeding at time of screening 15. Concurrent enrollment in anther&#xD;
        clinical study involving an investigational treatment that is not an extension of another&#xD;
        MedImmune study with the same investigational product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>101 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
    <country>France</country>
  </removed_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>December 27, 2019</last_update_submitted>
  <last_update_submitted_qc>December 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medi7247</keyword>
  <keyword>non small cell lung cancer</keyword>
  <keyword>head and neck cancer</keyword>
  <keyword>small cell lung cancer</keyword>
  <keyword>colorectal cancer</keyword>
  <keyword>prostate cancer</keyword>
  <keyword>pancreatic adenocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <!-- 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/NCT03811652
org study id: D8540C00002
nct id: NCT03811652
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To assess safety and tolerability, describe the dose-limiting toxicities, assess the
      preliminary antitumor activity, determine the maximum tolerated dose (MTD) or the highest
      protocol-defined dose (maximum administered dose) in the absence of establishing the MTD, and
      a recommended dose for further evaluation of MEDI7247 in patients with selected advanced or
      metastatic solid tumor malignancies that have received at least 1 prior line of treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of Adverse Events
time frame: From time of informed consent through 90 days post end of treatment
description: To assess the occurrence of adverse events
measure: Occurrence of Serious Adverse Events
time frame: From time of informed consent through 90 days post end of treatment
description: To assess the occurrence of serious adverse events
measure: Occurrence of Dose Limiting Toxicities
time frame: During the evaluation period of 21 days post first dose
description: To assess the occurrence of toxicities and abnormal laboratory results that may limit further dose administration
measure: Number of patients with changes in laboratory parameters from baseline
time frame: From time of informed consent through 90 days post end of treatment
description: To assess serum chemistry, hematology, urinalysis and coagulation parameters
measure: Number of patients with changes in vital signs parameters from baseline
time frame: from time of informed consent through 21 days post last dose
description: to assess changes in vital signs
measure: Number of patients with changes in electrocardiogram results from baseline
time frame: from time of informed consent through 21 days post last dose
description: to assess changes in ECG
measure: Percentage of patients with changes in laboratory parameters from baseline
time frame: from time of informed consent through 90 days post end of treatment
description: to assess changes in serum chemistry, hematology, urinalysis, and coagulation parameters
measure: MEDI7247 maximum observed concentration (Cmax)
time frame: From first dose through 90 days post end of treatment
description: To characterize MEDI7247 single agent Pharmacokinetics
measure: MEDI7247 terminal half life (t1/2)
time frame: From first dose through 90 days post end of treatment
description: To characterize single agent MEDI7247 pharmacokinetics
measure: MEDI7247 area under the concentration/time curve (AUC)
time frame: from first dose through 90 days post end of treatment
description: To characterize single agent MEDI7247 pharmacokinetics
measure: MEDI7247 clearance
time frame: from first dose through 90 days post end of treatment
description: to characterize the single agent MEDI7247 pharmacokinetics
measure: Number of subjects who develop anti-drug antibodies
time frame: first dose through 90 days post end of treatment
description: To characterize MEDI7247 immunogenicity
measure: Best Overall Response
time frame: From time of informed consent and up to 90 days post end of treatment
description: To assess antitumor activity of MEDI7247
measure: Objective Response Rate (ORR)
time frame: From time of informed consent and up to 2 years after last subject in
description: To assess antitumor activity of MEDI7247
measure: Time to Response (TTR)
time frame: From time of informed consent and up to 90 days post end of treatment
description: To assess antitumor activity of MEDI7247
measure: Duration of Response (DoR)
time frame: From time of informed consent and up to 2 years after last subject in
description: To assess antitumor activity of MEDI7247
measure: Progression Free Survival (PFS)
time frame: From time of informed consent and up to 2 years after last subject in
description: To assess the antitumor activity of MEDI7247
measure: Disease Control (DC)
time frame: From time of informed consent and up to 2 years after last subject in
description: To assess antitumor activity of MEDI7247
measure: Overall Survival (OS)
time frame: From time of informed consent and up to 2 years after last subject in
description: To assess antitumor activity of MEDI7247
arm group label: NSCLC-Sq/HNSCC
arm group type: Experimental
description: Patients with advanced or metastatic NSCLC-Sq or HNSCC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen (platinum-based for HNSCC). PDL-1 positive patients should have received previous PD-1 or PD-L1 inhibitor where available.
arm group label: Small Cell Lung Cancer
arm group type: Experimental
description: Patients with advanced SCLC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior standard of care regimen.
arm group label: Colorectal Cancer
arm group type: Experimental
description: Patients with metastatic adenocarcinoma of the colon or rectum who have received and have progressed, or have documented intolerance, on prior thymidylate synthase inhibitor (eg, 5-fluorouracil (5-FU), capecitabine, raltitrexed, tegafur-uracil (UFT), irinotecan, and oxaliplatin for metastatic disease. If patients progress within 6 months of their last dose of adjuvant therapy this should be considered as a line of therapy in the metastatic setting. Patients with known RAS wildtype tumors must have received and progressed, or have documented intolerance, on anti-EGFR antibody. Patients with microsatellite instability-high or deficient mismatch repair tumors, must have received and progressed, or have documented intolerance on a PD-1 inhibitor, or PD-1 inhibitor plus cytotoxic T-lymphocyte antigen-4 inhibitor treatment where available.
arm group label: Pancreatic Ductal Adenocarcinoma
arm group type: Experimental
description: Patients with unresectable, locally advanced or metastatic PDAC who have recurrence after, or are refractory or intolerant to standard therapy, including at least one prior line of treatment.
arm group label: Metastatic Castration-Resistant Prostate Cancer
arm group type: Experimental
description: Patients with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.
arm group label: Other advanced/metastatic target expressing solid tumors
arm group type: Experimental
description: Patients with advanced or metastatic solid tumors not defined by other treatment arms who have positive expression of the protein target and have exhausted all approved therapies
intervention type: Drug
intervention name: MEDI7247
description: Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
arm group label: Colorectal Cancer
arm group label: Metastatic Castration-Resistant Prostate Cancer
arm group label: NSCLC-Sq/HNSCC
arm group label: Other advanced/metastatic target expressing solid tumors
arm group label: Pancreatic Ductal Adenocarcinoma
arm group label: Small Cell Lung Cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 101 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Canada
country: United States
country: Australia
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Prostatic Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Colorectal Neoplasms
mesh term: Adenocarcinoma
mesh term: Small Cell Lung Carcinoma
mesh term: Squamous Cell Carcinoma of Head and Neck