Phase 12a Study of BMS-986523 Alone or With Other Anti-Cancer Drugs in Adults With Advanced Solid Tumors Featuring KRAS Alterations

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called BMS-986523 alone and in combination with other anti-cancer drugs in people with advanced solid tumors, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. The study is an open-label, phase 12a trial sponsored by Bristol-Myers Squibb, focusing on participants with specific genetic alterations KRAS mutations or amplifications and advanced disease stages. Participants will receive BMS-986523 alone or combined with other anti-cancer agents such as Gemcitabine, Nab-Paclitaxel, Cetuximab, or Pembrolizumab, each given at specified doses on designated days. The study includes multiple treatment groups arms A through F with no random assignment or masking, allowing researchers to observe the drug effects in different combinations. The trial will monitor participants for up to three years to assess safety and treatment responses. During the study, participants will undergo regular assessments to track adverse events, serious side effects, and any toxicities related to the treatments. Researchers will also evaluate the tumor response using standardized criteria and measure drug levels in the blood. Safety monitoring includes checking for events leading to treatment discontinuation or death. Participants will be followed for up to three years to collect comprehensive data on treatment impact and tolerability.

A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies