A Global Phase IIIa Study of Oral JAB-23E73 to Assess Safety and Early Anti-Cancer Effects in Adults With Advanced Solid Tumors Having KRAS Gene Changes

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the pan-KRAS inhibitor JAB-23E73 in adults with advanced solid tumors that have KRAS gene alterations, including mutations or amplifications. This open-label, multicenter study is conducted in two phases Phase 1 dose escalation and Phase IIa dose expansion. It aims to find the best dose and assess the drugs effects in patients with KRAS-altered non-small cell lung cancer and other tumors. The study involves taking JAB-23E73 orally as a single agent. In Phase 1, researchers will escalate doses to determine the maximum tolerated dose or recommended phase 2 dose. Following this, Phase 1b will optimize dosing, and Phase 2a will expand to test efficacy, safety, and drug behavior in selected patients. Two alternative doses will be selected for further evaluation based on earlier phase results. Participants will undergo regular assessments including tumor measurements using RECIST v1.1, organ function tests, and monitoring of adverse events and drug levels in the body. The primary outcomes include dose-limiting toxicities during Phase 1 and objective response rate during Phase 2a, with follow-up lasting up to approximately two years. Safety, progression, survival, and pharmacokinetic data will also be collected throughout the study period.

A Phase I/IIa Study of JAB-23E73 in Patients With Advanced Solid Tumors Harboring KRAS Gene Alteration