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
Allist Pharmaceuticals, Inc.
120 participants
Mar 4, 2025
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
Plain Language Summary
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Interventions
Usage and dosage: 25mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 50mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 75mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 100mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 125mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Locations(1)
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NCT06955988