A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Comb
The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies
| Condition(s) | Advanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies |
| Who can participate | Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification). * Participants must, for Arm D, have a PD-L1 expression (≥50%). * Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments. Exclusion Criteria * Participants must not have untreated central nervous system (CNS) metastases. * Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatm |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Bristol-Myers Squibb |
| Locations | Baltimore, Maryland, United States; San Antonio, Texas, United States; West Valley City, Utah, United States; Fairfax, Virginia, United States; Vancouver, British Columbia, Canada; Toronto, Ontario, Canada (+2 more sites) |
| Start date | 2025-11-25 |
| NCT ID | NCT07223047 |
| Official listing | https://clinicaltrials.gov/study/NCT07223047 |