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/NCT06024174</url>
    </required_header>
    <id_info>
      <org_study_id>CA126-0015</org_study_id>
      <secondary_id>2023-505070-15</secondary_id>
      <nct_id>NCT06024174</nct_id>
    </id_info>
    <brief_title>A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors</brief_title>
    <official_title>Phase 1/2 Open-label Study of BMS-986466 in Combination With Adagrasib With or Without Cetuximab in Participants With KRAS G12C-mutant Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bristol-Myers Squibb</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bristol-Myers Squibb</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>
        The purpose of this study is to find a safe, tolerable, and efficacious dose of BMS-986466&#xD;
        when given orally, in combination with adagrasib with or without cetuximab in participants&#xD;
        with advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC), pancreatic duct&#xD;
        adenocarcinoma (PDAC), biliary tract cancer (BTC), or colorectal cancer (CRC).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">July 25, 2029</completion_date>
    <primary_completion_date type="Anticipated">August 5, 2027</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with dose limiting toxicity (DLTs)</measure>
      <time_frame>Up to 28 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with serious adverse events (SAEs)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with AEs leading to discontinuation</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with deaths</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum observed plasma concentration (Cmax)</measure>
      <time_frame>Up to approximately 60 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to maximum concentration (Tmax)</measure>
      <time_frame>Up to approximately 60 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])</measure>
      <time_frame>Up to approximately 60 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS) assessed by BICR as per RECIST v1.1</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR) assessed by BICR as per RECIST v1.1</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR) assessed by BICR as per RECIST v1.1</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR)</measure>
      <time_frame>Up to approximately 4 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Part 2 only</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with serious adverse events (SAEs)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Part 2 only</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with AEs leading to discontinuation</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Part 2 only</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with deaths</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Part 2 only</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacodynamic (PD) profile as measured by phosphorylation of extracellular signal-regulated kinase (pERK) levels in blood</measure>
      <time_frame>Up to approximately 30 days</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">410</enrollment>
    <condition>Advanced Solid Tumors</condition>
    <arm_group>
      <arm_group_label>Part 1: DDI Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1: Dose Escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2: Dose Expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BMS-986466</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Part 1: DDI Cohort</arm_group_label>
      <arm_group_label>Part 1: Dose Escalation</arm_group_label>
      <arm_group_label>Part 2: Dose Expansion</arm_group_label>
      <other_name>BBP-398</other_name>
      <other_name>IACS-15509</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Adagrasib</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Part 1: DDI Cohort</arm_group_label>
      <arm_group_label>Part 1: Dose Escalation</arm_group_label>
      <arm_group_label>Part 2: Dose Expansion</arm_group_label>
      <other_name>MRTX849</other_name>
      <other_name>KRAZATI®</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cetuximab</intervention_name>
      <description>Specified dose on specified days</description>
      <arm_group_label>Part 1: Dose Escalation</arm_group_label>
      <arm_group_label>Part 2: Dose Expansion</arm_group_label>
      <other_name>Erbitux®</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Key Inclusion Criteria:&#xD;
  &#xD;
          Part 1:&#xD;
  &#xD;
            -  Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDAC&#xD;
               and BTC that has spread to other parts of the body and cannot be removed surgically,&#xD;
               may or may not have received previous treatment with KRAS G12C inhibitors.&#xD;
  &#xD;
            -  For NSCLC and CRC: Individuals must have a documented KRAS G12C mutation status from&#xD;
               NYS or FDA approved/cleared or CE marked test or, when such result is not available,&#xD;
               positive KRAS G12C mutation status should be confirmed by a central laboratory in&#xD;
               blood sample collected at the time of screening.&#xD;
  &#xD;
            -  For PDAC and BTC: Participants must have a documented KRAS G12Cmutation from NYS or&#xD;
               FDA-approved/cleared, or CE-marked test and blood samples will be collected only for&#xD;
               retrospective testing.&#xD;
  &#xD;
            -  Are relapsed or refractory to available standard of care treatments.&#xD;
  &#xD;
          Part 2:&#xD;
  &#xD;
            -  Individuals with a confirmed diagnosis of advanced KRAS G12C-mutant NSCLC (Part 2A) or&#xD;
               CRC (Part 2B) that has spread to other parts of the body and cannot be removed&#xD;
               surgically and have not received previous treatment with KRAS inhibitors.&#xD;
  &#xD;
            -  Individuals must have a documented KRAS G12C mutation from FDA or NYS approved/&#xD;
               cleared or CE marked test or, when such result is not available, positive KRAS G12C&#xD;
               mutation status should be confirmed by a central laboratory in blood sample and /or&#xD;
               tumor samples collected at the time of screening or from archival biopsies (less than&#xD;
               1 year old).&#xD;
  &#xD;
            -  Have failed or disease recurrence or are not able to tolerate after at least 1&#xD;
               pervious line of therapy.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Have tumors with known BARF V600X, PTPN11 or KRASQ61X mutations.&#xD;
  &#xD;
            -  Have or any significant heart disease or condition.&#xD;
  &#xD;
            -  Receiving any medications that are substrate of CYP3A4 or inducers and/ or inhibitors&#xD;
  &#xD;
          Note: Other protocol-defined inclusion/exclusion criteria 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>Bristol-Myers Squibb</last_name>
      <role>Study Director</role>
      <affiliation>Bristol-Myers Squibb</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BMS Study Connect Contact Center www.BMSStudyConnect.com</last_name>
      <phone>855-907-3286</phone>
      <email>Clinical.Trials@bms.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>First line of the email MUST contain the NCT# and Site #.</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Alabama at Birmingham</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35294-3300</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Bassel El-Rayes, Site 0072</last_name>
        <phone>404-778-1900</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Valkyrie Clinical Trials</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90067</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David Berz, Site 0047</last_name>
        <phone>424-535-1874</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Cancer &amp; Blood Center, LLC</name>
        <address>
          <city>Athens</city>
          <state>Georgia</state>
          <zip>30607</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>James Splichal, Site 0040</last_name>
        <phone>706-353-2990</phone>
      </contact>
    </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>
      <contact>
        <last_name>Martin Gutierrez, Site 0025</last_name>
        <phone>551-996-5863</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Atlantic Health System Morristown Medical Center</name>
        <address>
          <city>Morristown</city>
          <state>New Jersey</state>
          <zip>07960</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Angela Alistar, Site 0008</last_name>
        <phone>862-345-8666</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0075</name>
        <address>
          <city>Ciudad Autónoma de Buenos Aires</city>
          <state>Buenos Aires</state>
          <zip>C1426ANZ</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0075</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0084</name>
        <address>
          <city>ABB</city>
          <state>Ciudad Autónoma De Buenos Aires</state>
          <zip>C1199ABB</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0084</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0076</name>
        <address>
          <city>Buenos Aires</city>
          <zip>1431</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0076</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0077</name>
        <address>
          <city>Córdoba</city>
          <zip>X5000HWE</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0077</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0078</name>
        <address>
          <city>Elizabeth Vale</city>
          <state>South Australia</state>
          <zip>5112</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0078</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0049</name>
        <address>
          <city>Brussels</city>
          <state>Bruxelles-Capitale, Région De</state>
          <zip>1200</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0049</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0048</name>
        <address>
          <city>Gent</city>
          <state>Oost-Vlaanderen</state>
          <zip>9000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0048</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0050</name>
        <address>
          <city>Leuven</city>
          <state>Vlaams-Brabant</state>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0050</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0020</name>
        <address>
          <city>Lille</city>
          <zip>59037</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0020</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0082</name>
        <address>
          <city>Petah Tikva</city>
          <state>HaMerkaz</state>
          <zip>4941492</zip>
          <country>Israel</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0082</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0081</name>
        <address>
          <city>Tel Aviv</city>
          <state>Tell Abīb</state>
          <zip>6423906</zip>
          <country>Israel</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0081</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0043</name>
        <address>
          <city>Ravenna</city>
          <state>Emilia-Romagna</state>
          <zip>48121</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0043</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0042</name>
        <address>
          <city>Milan</city>
          <state>Milano</state>
          <zip>20162</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0042</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0046</name>
        <address>
          <city>Rome</city>
          <state>Roma</state>
          <zip>00144</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0046</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0065</name>
        <address>
          <city>Badalona</city>
          <state>Barcelona [Barcelona]</state>
          <zip>08916</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0065</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0069</name>
        <address>
          <city>Barcelona</city>
          <state>Barcelona [Barcelona]</state>
          <zip>08035</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0069</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0066</name>
        <address>
          <city>Madrid</city>
          <state>Madrid, Comunidad De</state>
          <zip>28009</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0066</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0070</name>
        <address>
          <city>Madrid</city>
          <state>Madrid, Comunidad De</state>
          <zip>28034</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0070</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0067</name>
        <address>
          <city>Madrid</city>
          <state>Madrid, Comunidad De</state>
          <zip>28041</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0067</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Local Institution - 0068</name>
        <address>
          <city>Sevilla</city>
          <zip>41013</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Site 0068</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Argentina</country>
      <country>Australia</country>
      <country>Belgium</country>
      <country>France</country>
      <country>Israel</country>
      <country>Italy</country>
      <country>Spain</country>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>BMS Clinical Trial Information</description>
    </link>
    <link>
      <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
      <description>FDA Safety Alerts and Recalls</description>
    </link>
    <link>
      <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
      <description>BMS Clinical Trial Patient Recruiting</description>
    </link>
    <link>
      <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
      <description>Investigator Inquiry Form</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>BMS-986466</keyword>
    <keyword>KRAS G12C-mutant</keyword>
    <keyword>Pancreatic duct adenocarcinoma</keyword>
    <keyword>Biliary tract cancer</keyword>
    <keyword>Colorectal cancer</keyword>
    <keyword>Non-small cell lung cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cetuximab</mesh_term>
      <mesh_term>Adagrasib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>See Plan Description</ipd_time_frame>
      <ipd_access_criteria>See Plan Description</ipd_access_criteria>
      <ipd_url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html</ipd_url>
    </patient_data>
    <!-- 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/NCT06024174
  org study id: CA126-0015
  secondary id: 2023-505070-15
  nct id: NCT06024174
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to find a safe, tolerable, and efficacious dose of BMS-986466
        when given orally, in combination with adagrasib with or without cetuximab in participants
        with advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC), pancreatic duct
        adenocarcinoma (PDAC), biliary tract cancer (BTC), or colorectal cancer (CRC).
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants with dose limiting toxicity (DLTs)
  time frame: Up to 28 days
  measure: Number of participants with adverse events (AEs)
  time frame: Up to approximately 2 years
  measure: Number of participants with serious adverse events (SAEs)
  time frame: Up to approximately 2 years
  measure: Number of participants with AEs leading to discontinuation
  time frame: Up to approximately 2 years
  measure: Number of participants with deaths
  time frame: Up to approximately 2 years
  measure: Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  time frame: Up to approximately 4 years
  measure: Maximum observed plasma concentration (Cmax)
  time frame: Up to approximately 60 days
  measure: Time to maximum concentration (Tmax)
  time frame: Up to approximately 60 days
  measure: Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
  time frame: Up to approximately 60 days
  measure: Progression-free survival (PFS) assessed by BICR as per RECIST v1.1
  time frame: Up to approximately 4 years
  measure: Disease Control Rate (DCR) assessed by BICR as per RECIST v1.1
  time frame: Up to approximately 4 years
  measure: Duration of Response (DOR) assessed by BICR as per RECIST v1.1
  time frame: Up to approximately 4 years
  measure: Time to response (TTR)
  time frame: Up to approximately 4 years
  measure: Number of participants with adverse events (AEs)
  time frame: Up to approximately 2 years
  description: Part 2 only
  measure: Number of participants with serious adverse events (SAEs)
  time frame: Up to approximately 2 years
  description: Part 2 only
  measure: Number of participants with AEs leading to discontinuation
  time frame: Up to approximately 2 years
  description: Part 2 only
  measure: Number of participants with deaths
  time frame: Up to approximately 2 years
  description: Part 2 only
  measure: Pharmacodynamic (PD) profile as measured by phosphorylation of extracellular signal-regulated kinase (pERK) levels in blood
  time frame: Up to approximately 30 days
  arm group label: Part 1: DDI Cohort
  arm group type: Experimental
  arm group label: Part 1: Dose Escalation
  arm group type: Experimental
  arm group label: Part 2: Dose Expansion
  arm group type: Experimental
  intervention type: Drug
  intervention name: BMS-986466
  description: Specified dose on specified days
  arm group label: Part 1: DDI Cohort
  arm group label: Part 1: Dose Escalation
  arm group label: Part 2: Dose Expansion
  other name: BBP-398
  other name: IACS-15509
  intervention type: Drug
  intervention name: Adagrasib
  description: Specified dose on specified days
  arm group label: Part 1: DDI Cohort
  arm group label: Part 1: Dose Escalation
  arm group label: Part 2: Dose Expansion
  other name: MRTX849
  other name: KRAZATI®
  intervention type: Drug
  intervention name: Cetuximab
  description: Specified dose on specified days
  arm group label: Part 1: Dose Escalation
  arm group label: Part 2: Dose Expansion
  other name: Erbitux®
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bristol-Myers Squibb
  role: Study Director
  affiliation: Bristol-Myers Squibb
  last name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  phone: 855-907-3286
  email: Clinical.Trials@bms.com
  last name: First line of the email MUST contain the NCT# and Site #.
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  country: Argentina
  country: Australia
  country: Belgium
  country: France
  country: Israel
  country: Italy
  country: Spain
  country: United States
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: BMS Clinical Trial Information
  url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
  description: FDA Safety Alerts and Recalls
  url: https://www.bmsstudyconnect.com/s/US/English/USenHome
  description: BMS Clinical Trial Patient Recruiting
  url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
  description: Investigator Inquiry Form
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Cetuximab
  mesh term: Adagrasib
  sharing ipd: Yes
  ipd description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: See Plan Description
  ipd access criteria: See Plan Description
  ipd url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html