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 expansi

Trial Details

NCT ID
NCT06955988
Phase
PHASE1
Sponsor
Allist Pharmaceuticals, Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • AST2303 Tablets(ABK3376 Tablets) ，25mg
  • AST2303 Tablets(ABK3376 Tablets) ，50mg
  • AST2303 Tablets(ABK3376 Tablets) ，75mg
  • AST2303 Tablets(ABK3376 Tablets) ，100mg
  • AST2303 Tablets(ABK3376 Tablets) ，125mg
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Have fully understood this test and voluntarily sign the informed consent
  • Age ≥ 18 at the time of signing the informed consent, regardless of gender
  • Patients with non-small cell lung cancer confirmed by tissue / cytology.
  • According to recist1.1 criteria, the presence of at least one target lesion without local treatment was assessed by the investigator

For full eligibility, visit ClinicalTrials.gov.

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