Advanced Solid TumorsPhase 1/2NCT06024174
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
A Phase 1/2 study testing BMS-986466, Adagrasib and Cetuximab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 9 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BMS-986466, Adagrasib and Cetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 9 Nov 2023to 13 May 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United States4 sites
Local Institution - 0040
Athens, Georgia, 30607
Local Institution - 0025
Hackensack, New Jersey, 07601
Local Institution - 0047
Los Angeles, California, 90067
Local Institution - 0008
Morristown, New Jersey, 07960
Israel2 sites
Local Institution - 0082
Petah Tikva, Central District, 4941492
Local Institution - 0081
Tel Aviv, Tell Abīb, 6423906
About this study
Official title: Phase 1/2 Open-label Study of BMS-986466 in Combination With Adagrasib With or Without Cetuximab in Participants With KRAS G12C-mutant Advanced 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).
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986466, Adagrasib, Cetuximab
- Keywords
- BMS-986466, KRAS G12C-mutant, Pancreatic duct adenocarcinoma, Biliary tract cancer, Colorectal cancer, Non-small cell lung cancer
- Medical subject headings
- Biliary Tract Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986466Drug
Also called BBP-398, IACS-15509
Specified dose on specified days
AdagrasibDrug
Also called MRTX849, KRAZATI®
Specified dose on specified days
CetuximabDrug
Also called Erbitux®
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: DDI Cohort | Experimental | Not described Receives: Drug: BMS-986466; Drug: Adagrasib |
| Part 1: Dose Escalation | Experimental | Not described Receives: Drug: BMS-986466; Drug: Adagrasib; Drug: Cetuximab |
| Part 2: Dose Expansion | Experimental | Not described Receives: Drug: BMS-986466; Drug: Adagrasib; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)
Secondary outcomes (12)
Part 1: Maximum Observed Plasma Concentration (Cmax)
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Cycle 1 Day 1 (Each cycle consist of 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start9 Nov 2023
- Primary completion13 May 2024
- Study completion13 May 2024
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024174
- Sponsor's protocol ID
- CA126-0015
- Other IDs
- 2023-505070-15, 2023
- Status last verified
- Jul 2025
- First submitted
- 29 Aug 2023
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Open-label Study of BMS-986466 in Combination With Adagrasib With or Without Cetuximab in Participants With KRAS G12C-mutant Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06024174
- Acronym / sponsor ID
- CA126-0015
- Conditions
- Advanced Solid Tumors
- Keywords
- BMS-986466, KRAS G12C-mutant, Pancreatic duct adenocarcinoma, Biliary tract cancer, Colorectal cancer, Non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: DDI Cohort | Experimental | Drug: BMS-986466, Drug: Adagrasib |
| Part 1: Dose Escalation | Experimental | Drug: BMS-986466, Drug: Adagrasib, Drug: Cetuximab |
| Part 2: Dose Expansion | Experimental | Drug: BMS-986466, Drug: Adagrasib, Drug: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986466Also: BBP-398, IACS-15509Specified dose on specified days | Drug | Part 1: DDI Cohort, Part 1: Dose Escalation, Part 2: Dose Expansion |
| AdagrasibAlso: MRTX849, KRAZATI®Specified dose on specified days | Drug | Part 1: DDI Cohort, Part 1: Dose Escalation, Part 2: Dose Expansion |
| CetuximabAlso: Erbitux®Specified dose on specified days | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
Part 1: Number of Participants With Dose Limiting Toxicity (DLTs)
Time frame: Cycle 1 (Each cycle consist of 28 days)
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
Part 1: Number of Participants With Adverse Events (AEs)
Time frame: From first dose until 100 days after last dose (Up to approximately 5 months)
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.
Part 1: Number of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose until 30 days after last dose (Up to approximately 3 months)
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.
Part 1: Number of Participants With AEs Leading to Discontinuation
Time frame: From first dose until 30 days after last dose (Up to approximately 3 months)
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
Part 1: Number of Participants Who Died
Time frame: From first dose until 100 days after last dose (Up to approximately 5 months)
Death due to any cause was assessed.
Part 2 Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)
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.
12 secondary outcomes
Part 1: Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1 (Each cycle consist of 28 days)
Part 1: Time to Maximum Concentration (Tmax)
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])
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
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
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
Time frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months)
Part 2- Time to Response (TTR)
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)
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)
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
Time frame: From first dose until 100 days after last dose (Up to approximately 5 months)
Part 2- Number of Participants Who Died
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
Time frame: Baseline and Cycle 1 Day 1 (Each cycle consist of 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986466, Adagrasib and Cetuximab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Israel, Australia, Finland, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Dose Limiting Toxicity (DLTs) (time frame: Cycle 1 (Each cycle consist of 28 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.