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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT06024174
Other study ID # CA126-0015
Secondary ID 2023-505070-15
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date November 9, 2023
Est. completion date May 13, 2024

Study information

Verified date May 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date May 13, 2024
Est. primary completion date May 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Key Inclusion Criteria: Part 1: - 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. 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/ or inhibitors Note: Other protocol-defined inclusion/exclusion criteria apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986466
Specified dose on specified days
Adagrasib
Specified dose on specified days
Cetuximab
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution - 0053 Westmead New South Wales
Finland Local Institution - 0083 Helsinki
France Local Institution - 0020 Lille
Israel Local Institution - 0082 Petah Tikva HaMerkaz
Israel Local Institution - 0081 Tel Aviv Tell Abib
United States Local Institution - 0040 Athens Georgia
United States Local Institution - 0025 Hackensack New Jersey
United States Local Institution - 0047 Los Angeles California
United States Local Institution - 0008 Morristown New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Finland,  France,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with dose limiting toxicity (DLTs) Up to 28 days
Primary Number of participants with adverse events (AEs) Up to approximately 2 years
Primary Number of participants with serious adverse events (SAEs) Up to approximately 2 years
Primary Number of participants with AEs leading to discontinuation Up to approximately 2 years
Primary Number of participants with deaths Up to approximately 2 years
Primary Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to approximately 4 years
Secondary Maximum observed plasma concentration (Cmax) Up to approximately 60 days
Secondary Time to maximum concentration (Tmax) Up to approximately 60 days
Secondary Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) Up to approximately 60 days
Secondary Progression-free survival (PFS) assessed by BICR as per RECIST v1.1 Up to approximately 4 years
Secondary Disease Control Rate (DCR) assessed by BICR as per RECIST v1.1 Up to approximately 4 years
Secondary Duration of Response (DOR) assessed by BICR as per RECIST v1.1 Up to approximately 4 years
Secondary Time to response (TTR) Up to approximately 4 years
Secondary Number of participants with adverse events (AEs) Part 2 only Up to approximately 2 years
Secondary Number of participants with serious adverse events (SAEs) Part 2 only Up to approximately 2 years
Secondary Number of participants with AEs leading to discontinuation Part 2 only Up to approximately 2 years
Secondary Number of participants with deaths Part 2 only Up to approximately 2 years
Secondary Pharmacodynamic (PD) profile as measured by phosphorylation of extracellular signal-regulated kinase (pERK) levels in blood Up to approximately 30 days
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