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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

NCT06955988 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Allist Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-04
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955988 on ClinicalTrials.gov