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
TerminatedPhase 1, PHASE2Results postedLast updated 22 July 2025
What this trial tests
Phase 1, PHASE2 trial testing BMS-986466 in Advanced Solid Tumors in 5 participants. Terminated before completion.
18 and older, any sex, with Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1: Number of Participants With Dose Limiting Toxicity (DLTs)Primary· 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 incr
Part 1: Number of Participants With Adverse Events (AEs)Primary· 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)Primary· 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 DiscontinuationPrimary· 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: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])Secondary· Cycle 1 Day 1 (Each cycle consist of 28 days)
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b.
Time frame: 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)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.
· EARLY_PHASE1
· recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 22 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06024174.