A Phase 1/2 interventional study of BMS-986466 and Adagrasib in Advanced Solid Tumors, sponsored by Bristol-Myers Squibb. Terminated at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment
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).
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's enrollment of 5 is below the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Key Inclusion Criteria:
Part 1:
Part 2:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply.
Drug: BMS-986466 · Drug: Adagrasib
Drug: BMS-986466 · Drug: Adagrasib · Drug: Cetuximab
Drug: BMS-986466 · Drug: Adagrasib · Drug: Cetuximab
Specified dose on specified days
Also known as: BBP-398, IACS-15509
Specified dose on specified days
Also known as: MRTX849, KRAZATI®
Specified dose on specified days
Also known as: Erbitux®
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)
Part 1: Maximum Observed Plasma Concentration (Cmax)
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Cycle 1 Day 1 (Each cycle consist of 28 days)
| Milestone | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Other reasons | 1 |
| Withdrew: Study terminated by sponsor | 4 |
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
| Participants | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicity (DLTs) | 0 |
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.
| Participants | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Number of Participants With Adverse Events (AEs) | 4 |
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.
| Participants | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Number of Participants With Serious Adverse Events (SAEs) | 1 |
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
| Participants | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Number of Participants With AEs Leading to Discontinuation | 0 |
Death due to any cause was assessed.
| Participants | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Number of Participants Who Died | 0 |
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.
No measurements were reported for this outcome.
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
| ng/mL | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Maximum Observed Plasma Concentration (Cmax) | NA ± NA |
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
| hours | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Time to Maximum Concentration (Tmax) | NA ± NA |
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
| mcg*hr/mL | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Part 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) | NA ± NA |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Death due to any cause was assessed.
No measurements were reported for this outcome.
Blood samples were collected for assessing pharmacodynamic parameters.
No measurements were reported for this outcome.
Collected over All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID | 0/5 (0%) | 1/5 (20%) | 4/5 (80%) |
| Event | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| PyrexiaGeneral disorders | 1/5 |
| Event | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| ConstipationGastrointestinal disorders | 2/5 |
| DiarrhoeaGastrointestinal disorders | 2/5 |
| NauseaGastrointestinal disorders | 2/5 |
| Epigastric discomfortGastrointestinal disorders | 1/5 |
| ProctalgiaGastrointestinal disorders | 1/5 |
| VomitingGastrointestinal disorders | 1/5 |
| FatigueGeneral disorders | 1/5 |
| Alanine aminotransferase increasedInvestigations | 1/5 |
| Amylase increasedInvestigations | 1/5 |
| Aspartate aminotransferase increasedInvestigations | 1/5 |
| Age, Continuous(years) | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Mean | 55.2 ± 7.16 |
| Sex: Female, Male(Participants) | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Female | 2 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 1 |
| Race/Ethnicity, Customized(Participants) | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID |
|---|---|
| BLACK OR AFRICAN AMERICAN | 1 |
| WHITE | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Supporting information: Study protocol, Sap, Csr
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