Trial results for a Phase 1/2 study investigating adagrasib in combination with BMS-986466, with or without cetuximab, for KRAS G12C-mutant solid tumors were posted on ClinicalTrials.gov on 2025-07-22. The study, which enrolled 5 participants, was terminated, with 0 dose-limiting toxicities (DLTs) reported in Part 1.
Background
The study aimed to evaluate the safety, tolerability, and efficacy of BMS-986466 in combination with adagrasib, with or without cetuximab. This combination was investigated 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).
Trial design
The study (NCT06024174) was a Phase 1/2 trial that enrolled 5 participants with advanced KRAS G12C-mutant solid tumors, including non-small cell lung cancer (NSCLC), pancreatic duct adenocarcinoma (PDAC), biliary tract cancer (BTC), or colorectal cancer (CRC). The trial investigated orally administered BMS-986466 in combination with adagrasib, with or without cetuximab. The primary objective was to find a safe, tolerable, and efficacious dose of the combination.
Key results
Results for Part 1, which focused on drug-drug interaction with BMS-986466 10 MG + Adagrasib 400MG BID, showed the following safety outcomes:
- Number of participants with Dose Limiting Toxicity (DLTs): 0 Participants
- Number of participants with Adverse Events (AEs): 4 Participants
- Number of participants with Serious Adverse Events (SAEs): 1 Participant
- Number of participants with AEs leading to discontinuation: 0 Participants
- Number of participants who died: 0 Participants
What this means
The termination of this Phase 1/2 study suggests that the investigation into the combination of BMS-986466 with adagrasib, with or without cetuximab, for KRAS G12C-mutant solid tumors did not proceed as initially planned. Despite the termination, the limited safety data from Part 1 indicated 0 dose-limiting toxicities, 4 adverse events, and 1 serious adverse event among the 5 enrolled participants. No participants discontinued due to adverse events or died during this part of the study. The small enrollment size means these safety findings are preliminary and cannot be broadly generalized.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06024174, titled "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," were posted on 2025-07-22 on clinicaltrials.gov.