NCT06955988

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

A Phase I Clinical 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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Locally Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AST2303 Tablets(ABK3376 Tablets) ，25mg	Usage and dosage: 25mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
DRUG	AST2303 Tablets(ABK3376 Tablets) ，50mg	Usage and dosage: 50mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
DRUG	AST2303 Tablets(ABK3376 Tablets) ，75mg	Usage and dosage: 75mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
DRUG	AST2303 Tablets(ABK3376 Tablets) ，100mg	Usage and dosage: 100mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
DRUG	AST2303 Tablets(ABK3376 Tablets) ，125mg	Usage and dosage: 125mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle

Timeline

• Start date: 2025-03-04
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-05-02
• Last updated: 2026-02-12

Locations

1 site across 1 country: China