OncoMatch/Clinical Trials/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
Is NCT06955988 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for locally advanced or metastatic non-small cell lung cancer.
Treatment: 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 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: EGFR c797s mutation
Disease stage
Metastatic disease required
the presence of at least one target lesion without local treatment was assessed by the investigator
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antitumor therapy targeting the C797S mutation
Previously received antitumor therapy targeting the c797s mutation
Cannot have received: systemic anti-tumor treatment
Exception: within 2 weeks before the first administration or within 5 half lives of the drug (whichever is longer)
Have received any systemic anti-tumor treatment (including anti-tumor drugs in clinical research stage) within 2 weeks before the first administration or within 5 half lives of the drug (whichever is longer)
Cannot have received: anti-tumor drugs with long half-life (e.g. immune checkpoint inhibitors)
Exception: within 4 weeks before the first administration
receiving anti-tumor drugs with long half-life, such as immune checkpoint inhibitors, within 4 weeks before the first administration
Cannot have received: cytotoxic drugs with significant delayed toxicity (e.g. mitomycin C) (mitomycin C)
Exception: within 6 weeks before the first administration
received cytotoxic drugs with significant delayed toxicity, such as mitomycin C, within 6 weeks before the first administration
Cannot have received: non-specific immunomodulatory agents, traditional Chinese medicine or traditional Chinese medicine preparations with approved anti-tumor indications
Exception: within 2 weeks before the first administration
Have received non-specific immunomodulatory agents, traditional Chinese medicine or traditional Chinese medicine preparations with approved anti-tumor indications within 2 weeks before the first administration
Cannot have received: local (non bone lesions) radiotherapy
Exception: within 4 weeks before the first dose
Local (non bone lesions) radiotherapy within 4 weeks before the first dose
Cannot have received: bone radiotherapy
Exception: within 2 weeks before the first dose
bone radiotherapy within 2 weeks before the first dose
Cannot have received: major surgery
Exception: within 4 weeks before the first dose or expected during the study period
Subjects who had undergone major surgery within 4 weeks before the first dose or were expected to undergo major surgery during the study period
Lab requirements
Blood counts
The subject's bone marrow and organ functions are good (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before the first administration)
Kidney function
The subject's bone marrow and organ functions are good (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before the first administration)
Liver function
The subject's bone marrow and organ functions are good (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before the first administration)
The subject's bone marrow and organ functions are good (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before the first administration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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