A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

This study is a multicenter, single arm, open label, phase I clinical trial, including dose escalation (phase IA) and dose expansion (phase IB). This study aimed to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of ast2303 tablets (abk3376 tablets) in subjects with locally advanced or metastatic non-small cell lung cancer. A safety review committee (SRC) was established in this study, which will review the safety, efficacy, pharmacokinetics and other data obtained from the study, and make decisions on key issues such as dose escalation and dose expansion.

NCT Number	NCT06955988
Lead Sponsor	Allist Pharmaceuticals, Inc.
Conditions	Locally Advanced or Metastatic Non-small Cell Lung Cancer
Enrollment	120 participants
Start Date	2025-03-04
Primary Completion	2026-12 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-13