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
NCT ID: NCT06024174
Last Updated: 2025-07-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
5 participants
INTERVENTIONAL
2023-11-09
2024-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: DDI Cohort
BMS-986466
Specified dose on specified days
Adagrasib
Specified dose on specified days
Part 1: Dose Escalation
BMS-986466
Specified dose on specified days
Adagrasib
Specified dose on specified days
Cetuximab
Specified dose on specified days
Part 2: Dose Expansion
BMS-986466
Specified dose on specified days
Adagrasib
Specified dose on specified days
Cetuximab
Specified dose on specified days
Interventions
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BMS-986466
Specified dose on specified days
Adagrasib
Specified dose on specified days
Cetuximab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDAC and 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 from NYS 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 in blood sample collected at the time of screening.
* For PDAC and BTC: Participants must have a documented KRAS G12Cmutation from NYS or FDA-approved/cleared, or CE-marked test and blood samples will be collected only for retrospective 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 removed surgically 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 G12C mutation status should be confirmed by a central laboratory in blood sample and /or tumor samples collected at the time of screening or from archival biopsies (less than 1 year old).
* Have failed or disease recurrence or are not able to tolerate after at least 1 pervious line of therapy.
Exclusion Criteria
* Have or any significant heart disease or condition.
* Receiving any medications that are substrate of CYP3A4 or inducers and/ or inhibitors
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0047
Los Angeles, California, United States
Local Institution - 0040
Athens, Georgia, United States
Local Institution - 0025
Hackensack, New Jersey, United States
Local Institution - 0008
Morristown, New Jersey, United States
Local Institution - 0053
Westmead, New South Wales, Australia
Local Institution - 0083
Helsinki, , Finland
Local Institution - 0020
Lille, , France
Local Institution - 0082
Petah Tikva, Central District, Israel
Local Institution - 0081
Tel Aviv, Tell Abīb, Israel
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-505070-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA126-0015
Identifier Type: -
Identifier Source: org_study_id
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