A Single-arm, Multicenter, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JAB-21822 Monotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.

What this Trial Is About

Researchers are studying adult patients with locally advanced or metastatic solid tumors that have a specific KRAS p.G12C mutation, focusing on pancreatic cancer and other solid tumors that have progressed after prior treatments or are intolerant to them. The trial aims to evaluate the safety and effectiveness of the drug Glecirasib in these patients. This is a pivotal, single-arm, open-label phase II trial involving multiple centers. Participants will receive Glecirasib orally at a dose of 800 mg once daily in cycles of 21 days. Treatment will continue until the disease progresses, intolerable side effects occur, or the participant withdraws for other reasons. The study includes patients with advanced pancreatic cancer who have not responded to certain chemotherapy regimens or patients with other solid tumors excluding NSCLC and CRC who have limited treatment options. During the study, participants will be monitored for tumor response using independent radiological reviews according to RECIST 1.1 criteria over approximately 1.5 years. Researchers will assess outcomes such as objective response rate, duration and time to response, progression-free survival, disease control rate, and overall survival. Safety will be followed by tracking adverse events. The total observation period may extend up to about 2 years to fully evaluate these outcomes.

A Phase II Study Evaluating JAB-21822 Monotherapy in Adult Patients With Pancreatic Cancer and Other Solid Tumors Harboring the KRAS p.G12C Mutation.