xml: <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/NCT06040541</url>
    </required_header>
    <id_info>
      <org_study_id>RMC-9805-001</org_study_id>
      <nct_id>NCT06040541</nct_id>
    </id_info>
    <brief_title>Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors</brief_title>
    <official_title>Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG12D-Mutant Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Revolution Medicines, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Revolution Medicines, Inc.</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is to evaluate the safety and tolerability of RMC-9805 in adults with KRAS&#xD;
        G12D-mutant solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label, multicenter, Phase 1/1b study of RMC-9805, monotherapy, selective and&#xD;
        orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to&#xD;
        evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity.&#xD;
        The study consists of two parts: Part 1- Dose-Exploration and Part 2- Dose-Expansion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Up to 3 years</time_frame>
      <description>Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dose Limiting Toxicities</measure>
      <time_frame>21 days</time_frame>
      <description>Number of participants with Dose Limiting Toxicities (DLTs)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum Observed Blood Concentration (Cmax) of RMC-9805</measure>
      <time_frame>up to 21 weeks</time_frame>
      <description>Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805</measure>
      <time_frame>up to 21 weeks</time_frame>
      <description>Tmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under Blood Concentration Time Curve (AUC) of RMC-9805</measure>
      <time_frame>up to 21 weeks</time_frame>
      <description>AUC</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ratio of accumulation of RMC-9805 from a single dose to steady state with repeated dosing</measure>
      <time_frame>up to 21 weeks</time_frame>
      <description>accumulation ratio of RMC-9805</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination Half-Life (t1/2) of RMC-9805</measure>
      <time_frame>up to 21 weeks</time_frame>
      <description>t1/2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Assess per RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Assess per RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Assess per RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Response (TTR)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Assess per RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Survival (PFS)</measure>
      <time_frame>up to 3 years</time_frame>
      <description>Assess per RECIST v1.1</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">290</enrollment>
    <condition>Non-small Cell Lung Cancer (NSCLC)</condition>
    <condition>Colorectal Cancer (CRC)</condition>
    <condition>Pancreatic Ductal Adenocarcinoma (PDAC)</condition>
    <condition>Advanced Solid Tumors</condition>
    <arm_group>
      <arm_group_label>RMC-9805</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dose exploration and dose expansion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RMC-9805</intervention_name>
      <description>Oral Tablets</description>
      <arm_group_label>RMC-9805</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathologically documented, locally advanced or metastatic solid tumor malignancy with&#xD;
               KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or&#xD;
               polymerase chain reaction (PCR) test&#xD;
  &#xD;
            -  Received and progressed or been intolerant to prior standard therapy (including&#xD;
               targeted therapy) appropriate for tumor type and stage&#xD;
  &#xD;
            -  ECOG performance status 0 or 1&#xD;
  &#xD;
            -  Adequate organ function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Primary central nervous system (CNS) tumors&#xD;
  &#xD;
            -  Known or suspected leptomeningeal or active brain metastases or spinal cord&#xD;
               compression&#xD;
  &#xD;
            -  Known or suspected impairment of gastrointestinal function that may prohibit ability&#xD;
               to swallow or absorb an oral medication&#xD;
  &#xD;
            -  Participant was previously treated with an investigational KRASG12D inhibitor or had&#xD;
               prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)&#xD;
  &#xD;
          Other inclusion/exclusion criteria may apply.&#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>Revolution Medicines, Inc.</last_name>
      <role>Study Director</role>
      <affiliation>Revolution Medicines, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Revolution Medicines, Inc.</last_name>
      <phone>(650) 779-2300</phone>
      <email>CT-inquiries@RevMed.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>START</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>NEXT Oncology Virginia</name>
        <address>
          <city>Fairfax</city>
          <state>Virginia</state>
          <zip>22031</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</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 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>KRAS G12D (ON)</keyword>
    <keyword>NSCLC</keyword>
    <keyword>CRC</keyword>
    <keyword>PDAC</keyword>
    <keyword>Non-small Cell Lung Cancer</keyword>
    <keyword>Lung Cancer</keyword>
    <keyword>Colorectal Cancer</keyword>
    <keyword>Colon Cancer</keyword>
    <keyword>Pancreatic Cancer</keyword>
    <keyword>Metastatic Cancer</keyword>
    <keyword>Pancreatic Ductal Adenocarcinoma</keyword>
    <keyword>Pancreatic Neoplasms</keyword>
    <keyword>Colorectal Neoplasms</keyword>
    <keyword>Gastrointestinal Neoplasms</keyword>
    <keyword>KRAS</keyword>
    <keyword>Colonic Neoplasms</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Adenocarcinoma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040541
  org study id: RMC-9805-001
  nct id: NCT06040541
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study is to evaluate the safety and tolerability of RMC-9805 in adults with KRAS
        G12D-mutant solid tumors.
  This is an open-label, multicenter, Phase 1/1b study of RMC-9805, monotherapy, selective and
        orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to
        evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity.
        The study consists of two parts: Part 1- Dose-Exploration and Part 2- Dose-Expansion.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Adverse events
  time frame: Up to 3 years
  description: Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
  measure: Dose Limiting Toxicities
  time frame: 21 days
  description: Number of participants with Dose Limiting Toxicities (DLTs)
  measure: Maximum Observed Blood Concentration (Cmax) of RMC-9805
  time frame: up to 21 weeks
  description: Cmax
  measure: Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805
  time frame: up to 21 weeks
  description: Tmax
  measure: Area Under Blood Concentration Time Curve (AUC) of RMC-9805
  time frame: up to 21 weeks
  description: AUC
  measure: Ratio of accumulation of RMC-9805 from a single dose to steady state with repeated dosing
  time frame: up to 21 weeks
  description: accumulation ratio of RMC-9805
  measure: Elimination Half-Life (t1/2) of RMC-9805
  time frame: up to 21 weeks
  description: t1/2
  measure: Overall Response Rate (ORR)
  time frame: up to 3 years
  description: Assess per RECIST v1.1
  measure: Duration of Response (DOR)
  time frame: up to 3 years
  description: Assess per RECIST v1.1
  measure: Disease Control Rate (DCR)
  time frame: up to 3 years
  description: Assess per RECIST v1.1
  measure: Time to Response (TTR)
  time frame: up to 3 years
  description: Assess per RECIST v1.1
  measure: Progression-Free Survival (PFS)
  time frame: up to 3 years
  description: Assess per RECIST v1.1
  arm group label: RMC-9805
  arm group type: Experimental
  description: Dose exploration and dose expansion
  intervention type: Drug
  intervention name: RMC-9805
  description: Oral Tablets
  arm group label: RMC-9805
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Revolution Medicines, Inc.
  role: Study Director
  affiliation: Revolution Medicines, Inc.
  last name: Revolution Medicines, Inc.
  phone: (650) 779-2300
  email: CT-inquiries@RevMed.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Colorectal Neoplasms
  mesh term: Adenocarcinoma