Phase 1 Study to Evaluate Safety and Effectiveness of Calderasib Alone and with Other Therapies in Adults With KRAS G12C Mutant Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, how the body processes the drug, and the effects of calderasib alone and in combination with other therapies in adults with advanced solid tumors that have a specific genetic mutation called KRAS G12C. This study focuses on participants with measurable disease and adequate organ function who have this mutation confirmed by tissue or blood testing. It is a Phase 1 trial aiming to understand treatment tolerability and effectiveness in this patient group. Participants receive different study treatments depending on their assigned group. Some receive daily oral escalating doses of calderasib up to 800 mg until the disease progresses or treatment stops. Others receive calderasib combined with pembrolizumab infusions every 21 days for up to about 24 months, sometimes along with other chemotherapy drugs like carboplatin, pemetrexed, cetuximab, oxaliplatin, leucovorin, and 5-fluorouracil, given according to standard dosing schedules. Dosing may be adjusted based on safety. The study includes several treatment arms with different combinations. During the study, participants undergo regular safety monitoring, including tracking dose-limiting toxicities and adverse events over approximately 56 months. Researchers measure treatment effects, such as tumor response and duration, and study how calderasib behaves in the body through blood tests at designated times during treatment cycles. Participants will be followed through multiple cycles lasting 3 or 4 weeks depending on the arm, with assessments continuing for up to about 56 months to capture long-term effects and safety.

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)