Study of Oral JAB-21822 in Advanced or Metastatic Non-Small Cell Lung Cancer with KRAS p.G12C and STK11 Co-Mutations and KEAP1 Wild-Type

What this Trial Is About

Researchers are evaluating the safety, tolerability, drug levels, and early clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have tumors with a KRAS p.G12C mutation and a co-mutation in STK11, while having wild-type KEAP1. This trial includes patients who are either newly diagnosed or have received at least one prior treatment for advanced disease. The study is a Phase IbII, open-label, multi-center trial sponsored by Allist Pharmaceuticals, Inc. The study includes a Dose Escalation phase where JAB-21822 is given as a monotherapy to find the maximum tolerated dose MTD and recommended Phase 2 dose RP2D. After this, there are two Dose Expansion parts Part 1 tests safety and clinical activity in patients who have not been treated before, and Part 2 evaluates the same outcomes in patients who have had at least one previous systemic therapy. JAB-21822 is administered orally throughout the study. Participants will be monitored for dose-limiting toxicities and adverse events during the Dose Escalation phase and safety and clinical responses during the Dose Expansion phases for up to three years. Researchers will assess tumor responses using objective response rates and other measures like progression-free survival and overall survival. Drug plasma levels will also be tracked. This comprehensive monitoring includes regular clinical evaluations and follow-up to understand the drugs effects and safety over time.

A Study of JAB-21822 in Advanced or Metastatic NSCLC With KRAS p.G12C and STK11 Co-mutation and Wild-type KEAP1