RecruitingPhase 1NCT06955988

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


Sponsor

Allist Pharmaceuticals, Inc.

Enrollment

120 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new targeted drug for people with non-small cell lung cancer (NSCLC) whose tumor has a specific genetic mutation called C797S in the EGFR gene — a mutation that commonly develops as resistance to previous EGFR-targeted therapies. This drug is designed to overcome that resistance and re-control the cancer. **You may be eligible if...** - You are 18 or older with confirmed non-small cell lung cancer - You have at least one measurable tumor that has not been locally treated - Your tumor has the C797S EGFR mutation or another specific EGFR change that makes you likely to respond to this drug - Your overall health (ECOG score 0 or 1) is good enough to tolerate the study drug - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have previously received a drug targeting the C797S mutation - Your cancer has other known driver gene mutations that would indicate a different treatment - You received another cancer drug within the past 2 weeks or within 5 half-lives of that drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAST2303 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

DRUGAST2303 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

DRUGAST2303 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

DRUGAST2303 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

DRUGAST2303 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


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06955988


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