Phase 12 Study of BLU-924 SAR449336 to Assess Safety and Effectiveness in Advanced Pancreatic, Lung, and Colorectal Cancers with KRAS Mutations

What this Trial Is About

Researchers are studying BLU-924 SAR449336, a pan-KRAS inhibitor, in people with advanced pancreatic ductal adenocarcinoma, non-small cell lung cancer, or colorectal cancer that have specific KRAS mutations. This open-label Phase 12 trial aims to evaluate the safety, tolerability, how the drug moves through the body, and its antitumor effects in these participants. The study focuses on metastatic cancers with KRAS mutations and includes multiple stages to determine appropriate dosing and preliminary efficacy. Participants will receive BLU-924 as an oral tablet once daily during Dose Escalation, Dose Enrichment, and Dose Expansion phases. Dose Escalation and Enrichment are used to find the maximum tolerated dose and recommended dose for expansion, with dose levels adjusted based on safety and tolerability. Dose Expansion further studies safety and antitumor activity at the recommended dose in specific cancer types harboring KRAS mutations. There is no active combination treatment arm at this time. Throughout the study, participants undergo safety monitoring, evaluation of side effects, and pharmacokinetic assessments. Researchers will measure dose-limiting toxicities, adverse events, response rates, duration of response, disease control, progression-free survival, and overall survival over a follow-up period of up to five years. Blood tests, tumor imaging, and other clinical assessments will be conducted regularly to observe treatment impact and drug behavior in the body.

A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations