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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 | 2025-05-05 | 2025-07-20 |
2023-08-29 | 2025-07-20 | 2025-07-22 |
2023-09-06 | 2025-07-22 | 2025-07 |
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 |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicity (DLTs) | A DLT was defined as: * Death not related to disease progression * Grade (Gr) 4 (Life-threatening) neurotoxicity * Gr 3 (Severe) neurotoxicity of greater than 7 days * Gr 3 neurotoxicity does not revert to baseline within 28 days of the start date of the Grade 3 event * Seizures of grade that do not resolve within 7 days * Gr 4 cytokine release syndrome (CRS) that does not resolve to less than or equal to Gr 3 within 3 days * Gr 3 CRS that does not resolve to less than or equal to Grade 2 within 7 days * Any increase in aspartate aminotransferase (AST) or ALT \> 3 Ã- ULN and concurrent increase in total bilirubin \> 2 Ã- ULN that is unrelated to CRS and has no other probable reason to explain the combination of increases * Any other Gr 3 or 4 event deemed unexpected by the Investigator and considered a DLT upon evaluation by the safety review committee | Cycle 1 (Each cycle consist of 28 days) |
| Part 1: Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 1: Number of Participants With Serious Adverse Events (SAEs) | A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. | From first dose until 30 days after last dose (Up to approximately 3 months) |
| Part 1: Number of Participants With AEs Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatmen | From first dose until 30 days after last dose (Up to approximately 3 months) |
| Part 1: Number of Participants Who Died | Death due to any cause was assessed. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2 Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Objective Response Rate (ORR) is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Plasma Concentration (Cmax) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Cycle 1 Day 1 (Each cycle consist of 28 days) |
| Part 1: Time to Maximum Concentration (Tmax) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Cycle 1 Day 1 (Each cycle consist of 28 days) |
| Part 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Cycle 1 Day 1 (Each cycle consist of 28 days) |
| Part 2-Progression-free Survival (PFS) Assessed by BICR as Per RECIST v1.1 | Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Disease Control Rate (DCR) Assessed by BICR as Per RECIST v1.1 | Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Duration of Response (DOR) Assessed by BICR as Per RECIST v1.1 | Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Time to Response (TTR) | Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2- Number of Participants With Serious Adverse Events (SAEs) | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2- Number of Participants With AEs Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2- Number of Participants Who Died | Death due to any cause was assessed. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 1a and 1b - Changes From Baseline in Pharmacodynamic Biomarker | Blood samples were collected for assessing pharmacodynamic parameters. | Baseline and Cycle 1 Day 1 (Each cycle consist of 28 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
