2023-11-09
2024-05-13
2024-05-13
5
NCT06024174
Bristol-Myers Squibb
Bristol-Myers Squibb
INTERVENTIONAL
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
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).
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-08-29 | N/A | 2024-06-07 |
2023-08-29 | N/A | 2024-06-10 |
2023-09-06 | N/A | 2024-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Part 1: DDI Cohort | DRUG: BMS-986466
DRUG: Adagrasib
|
| EXPERIMENTAL: Part 1: Dose Escalation | DRUG: BMS-986466
DRUG: Adagrasib
DRUG: Cetuximab
|
| EXPERIMENTAL: Part 2: Dose Expansion | DRUG: BMS-986466
DRUG: Adagrasib
DRUG: Cetuximab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicity (DLTs) | Up to 28 days | |
| Number of participants with adverse events (AEs) | Up to approximately 2 years | |
| Number of participants with serious adverse events (SAEs) | Up to approximately 2 years | |
| Number of participants with AEs leading to discontinuation | Up to approximately 2 years | |
| Number of participants with deaths | Up to approximately 2 years | |
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to approximately 60 days | |
| Time to maximum concentration (Tmax) | Up to approximately 60 days | |
| 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 | |
| Progression-free survival (PFS) assessed by BICR as per RECIST v1.1 | Up to approximately 4 years | |
| Disease Control Rate (DCR) assessed by BICR as per RECIST v1.1 | Up to approximately 4 years | |
| Duration of Response (DOR) assessed by BICR as per RECIST v1.1 | Up to approximately 4 years | |
| Time to response (TTR) | Up to approximately 4 years | |
| Number of participants with adverse events (AEs) | Part 2 only | Up to approximately 2 years |
| Number of participants with serious adverse events (SAEs) | Part 2 only | Up to approximately 2 years |
| Number of participants with AEs leading to discontinuation | Part 2 only | Up to approximately 2 years |
| Number of participants with deaths | Part 2 only | Up to approximately 2 years |
| Pharmacodynamic (PD) profile as measured by phosphorylation of extracellular signal-regulated kinase (pERK) levels in blood | Up to approximately 30 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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