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

Last updated: June 7, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Terminated

Phase

1/2

Condition

Neoplasms

Treatment

Cetuximab

BMS-986466

Adagrasib

Clinical Study ID

NCT06024174
CA126-0015
2023-505070-15
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Key Inclusion Criteria:

Part 1:

  • Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDACand BTC that has spread to other parts of the body and cannot be removed surgically,may or may not have received previous treatment with KRAS G12C inhibitors.

  • For NSCLC and CRC: Individuals must have a documented KRAS G12C mutation status fromNYS or FDA approved/cleared or CE marked test or, when such result is not available,positive KRAS G12C mutation status should be confirmed by a central laboratory inblood sample collected at the time of screening.

  • For PDAC and BTC: Participants must have a documented KRAS G12Cmutation from NYS orFDA-approved/cleared, or CE-marked test and blood samples will be collected only forretrospective testing.

  • Are relapsed or refractory to available standard of care treatments.

Part 2:

  • Individuals with a confirmed diagnosis of advanced KRAS G12C-mutant NSCLC (Part 2A)or CRC (Part 2B) that has spread to other parts of the body and cannot be removedsurgically and have not received previous treatment with KRAS inhibitors.

  • Individuals must have a documented KRAS G12C mutation from FDA or NYS approved/cleared or CE marked test or, when such result is not available, positive KRAS G12Cmutation status should be confirmed by a central laboratory in blood sample and /ortumor samples collected at the time of screening or from archival biopsies (lessthan 1 year old).

  • Have failed or disease recurrence or are not able to tolerate after at least 1pervious line of therapy.

Exclusion

Key Exclusion Criteria:

  • Have tumors with known BARF V600X, PTPN11 or KRASQ61X mutations.

  • Have or any significant heart disease or condition.

  • Receiving any medications that are substrate of CYP3A4 or inducers and/ orinhibitors

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 5
Treatment Group(s): 3
Primary Treatment: Cetuximab
Phase: 1/2
Study Start date:
November 09, 2023
Estimated Completion Date:
May 13, 2024

Connect with a study center

  • Local Institution - 0075

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ANZ
    Argentina

    Site Not Available

  • Local Institution - 0084

    ABB, Ciudad Autónoma De Buenos Aires C1199ABB
    Argentina

    Site Not Available

  • Local Institution - 0076

    Buenos Aires, 1431
    Argentina

    Site Not Available

  • Local Institution - 0077

    Córdoba, X5000HWE
    Argentina

    Site Not Available

  • Local Institution - 0086

    Córdoba, 5002
    Argentina

    Site Not Available

  • Local Institution - 0053

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Local Institution - 0078

    Elizabeth Vale, South Australia 5112
    Australia

    Site Not Available

  • Local Institution - 0049

    Brussels, Bruxelles-Capitale, Région De 1200
    Belgium

    Site Not Available

  • Local Institution - 0048

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • Local Institution - 0050

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Local Institution - 0083

    Helsinki, 00029
    Finland

    Site Not Available

  • CHU de Bordeaux Hop St ANDRE

    Bordeaux, Aquitaine 33075
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Bouches-du-Rhône 13385
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Site Not Available

  • Hopital Claude Huriez - CHU de Lille

    Lille, 59037
    France

    Site Not Available

  • Local Institution - 0020

    Lille, 59037
    France

    Site Not Available

  • Local Institution - 0082

    Petah Tikva, HaMerkaz 4941492
    Israel

    Site Not Available

  • Local Institution - 0081

    Tel Aviv, Tell Abīb 6423906
    Israel

    Site Not Available

  • Local Institution - 0043

    Ravenna, Emilia-Romagna 48121
    Italy

    Site Not Available

  • Local Institution - 0042

    Milan, Milano 20162
    Italy

    Site Not Available

  • Local Institution - 0046

    Rome, Roma 00144
    Italy

    Site Not Available

  • Local Institution - 0065

    Badalona, Barcelona [Barcelona] 08916
    Spain

    Site Not Available

  • Local Institution - 0069

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Site Not Available

  • Local Institution - 0066

    Madrid, Madrid, Comunidad De 28009
    Spain

    Site Not Available

  • Local Institution - 0067

    Madrid, Madrid, Comunidad De 28041
    Spain

    Site Not Available

  • Local Institution - 0070

    Madrid, Madrid, Comunidad De 28034
    Spain

    Site Not Available

  • Local Institution - 0068

    Sevilla, 41013
    Spain

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • Local Institution - 0047

    Los Angeles, California 90067
    United States

    Site Not Available

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • Local Institution - 0040

    Athens, Georgia 30607
    United States

    Site Not Available

  • University Cancer & Blood Center, LLC

    Athens, Georgia 30607
    United States

    Site Not Available

  • University Cancer Blood Ctr

    Athens, Georgia 30607
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Local Institution - 0025

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Atlantic Health System Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Local Institution - 0008

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York 10016
    United States

    Site Not Available

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