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Also known as AST2303 Tablets(ABK3376 Tablets) ，25mg
AST2303 ， · 1 trial · 1 indication
AE will be classified based on the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) of the International Conference on Harmonisation of Registration Techniques for Medicinal Products for Human Use (ICH), and graded according to CTCAE 5.0.
ORR is defined as the proportion of subjects confirmed as CR or PR to the total number of subjects, and the confirmation of remission is based on a follow-up evaluation conducted at least 28 days apart using the RECIST v1.1 evaluation criteria.
DCR is defined as the sum of the proportions of subjects whose disease is confirmed to have improved (including CR, PR) or stabilized (SD) after the start of treatment.
DOR is defined as the time from the first recorded CR or PR to the first recorded imaging of disease progression (evaluated according to RECIST v1.1 criteria) or death from any cause (whichever occurs first) in a subject confirmed as ORR. Subjects who did not report disease progression or death during analysis will be subject to deletion on the date of the last tumor assessment.
PFS is defined as the time from the date of first medication to the date of first recorded disease progression (evaluated according to RECIST v1.1 criteria) or death from any cause (whichever occurs first).
OS is defined as the time from the date of initial medication to the date of death from any cause (whichever occurs first). Subjects who were not reported as deceased during the analysis, or subjects who were reported dead but had an unknown date of death (i.e. missing year, month, day, etc.), will be deleted from the last known date of survival.
| Arm | Type | Description |
|---|---|---|
| AST2303 Tablets(ABK3376 Tablets) ，25mg | EXPERIMENTAL | AST2303 Tablets(ABK3376 Tablets) ，25mg |
| AST2303 Tablets(ABK3376 Tablets) ，50mg | EXPERIMENTAL | AST2303 Tablets(ABK3376 Tablets) ，50mg |
| AST2303 Tablets(ABK3376 Tablets) ，75mg | EXPERIMENTAL | AST2303 Tablets(ABK3376 Tablets) ，75mg |
| AST2303 Tablets(ABK3376 Tablets) ，100mg | EXPERIMENTAL | AST2303 Tablets(ABK3376 Tablets) ，100mg |
| AST2303 Tablets(ABK3376 Tablets) ，125mg | EXPERIMENTAL | AST2303 Tablets(ABK3376 Tablets) ，125mg |
| Name | Type | Description |
|---|---|---|
| AST2303 Tablets(ABK3376 Tablets) ，25mg | DRUG | Usage and dosage: 25mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle |
| AST2303 Tablets(ABK3376 Tablets) ，50mg | DRUG | Usage and dosage: 50mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle |
| AST2303 Tablets(ABK3376 Tablets) ，75mg | DRUG | Usage and dosage: 75mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle |
| AST2303 Tablets(ABK3376 Tablets) ，100mg | DRUG | Usage and dosage: 100mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle |
| AST2303 Tablets(ABK3376 Tablets) ，125mg | DRUG | Usage and dosage: 125mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle |
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...
AST2303 is an investigational small molecule being developed for the treatment of locally advanced or metastatic non-small cell lung cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AST2303 is being developed by ArriVent BioPharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AVBP. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
AST2303 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety, tolerability, pharmacokinetics, and efficacy.
AST2303 is being evaluated in a Phase 1 clinical trial registered as NCT06955988. This study is recruiting patients with locally advanced or metastatic non-small cell lung cancer in China and aims to enroll approximately 120 participants aged 18 years and older.
Yes, AST2303 is also known as ABK3376. The drug is referred to as AST2303 Tablets (ABK3376 Tablets) in clinical trial documentation, and both names refer to the same investigational medication.
The clinical trial for AST2303 is biomarker-selected, meaning that patient enrollment is guided by the presence of specific biomarkers. However, the specific molecular target of the drug has not been disclosed in the available information.