Phase 2 Study of ABSK043 and Glecirasib Combination for Advanced or Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation

What this Trial Is About

Researchers are studying a combination therapy using ABSK043 and Glecirasib for patients with locally advanced or metastatic Non-Small Cell Lung Cancer NSCLC who have a specific KRASG12C mutation. This open-label phase 2 study aims to evaluate the safety, tolerability, early effectiveness, and how the body processes these drugs. The research includes both patients previously treated and those who have not received prior systemic therapy for their advanced cancer. The study is divided into an escalation part and an expansion part. In the escalation phase, different doses of ABSK043 combined with Glecirasib are tested to find a recommended dose based on safety and drug behavior. The expansion phase further assesses this doses safety, drug levels in the body, and anti-tumor effects. Treatment is given in 21-day cycles, and patients continue the combination therapy until the disease progresses, unacceptable side effects occur, or other study endpoints are reached. Participants undergo regular evaluations including safety monitoring for side effects, laboratory tests for drug levels, and tumor assessments using standard criteria. The research team tracks adverse events from consent through up to 30 months after the last dose. Researchers measure outcomes like dose-limiting toxicities after the first cycle and overall tumor response up to 50 months. This comprehensive follow-up helps understand both short- and long-term effects of the treatment.

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib