A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Ta
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 adva
| Condition(s) | Locally Advanced or Metastatic Non-small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Have fully understood this test and voluntarily sign the informed consent 2. Age ≥ 18 at the time of signing the informed consent, regardless of gender 3. Patients with non-small cell lung cancer confirmed by tissue / cytology. 4. According to recist1.1 criteria, the presence of at least one target lesion without local treatment was assessed by the investigator 5. Agree to provide blood samples and / or tumor tissue samples (fresh tissue or paraffin embedded tissue) for genetic testing 6. 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) 7. The ECoG physical status score is 0 or 1 8. Expected survival time ≥ 12 weeks 9. Have normal swallowing function 1 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Allist Pharmaceuticals, Inc. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-03-04 |
| NCT ID | NCT06955988 |
| Official listing | https://clinicaltrials.gov/study/NCT06955988 |