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.
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
Previously received antitumor therapy targeting the c797s mutation
Carry any other known driver gene alterations
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); Or receiving anti-tumor drugs with long half-life, such as immune checkpoint inhibitors, within 4 weeks before the first administration; Or received cytotoxic drugs with significant delayed toxicity, such as mitomycin C, within 6 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
Sequential
AST2303 Tablets(ABK3376 Tablets) ，25mg
DrugUsage 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
DrugUsage 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
DrugUsage 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
DrugUsage 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
DrugUsage and dosage: 125mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Adverse Event, AE
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.
Serious Adverse Event (SAE)
Adverse Events of Special Concern (AESI)
Objective response rate (ORR)
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.
Peak Time (Tmax)
Peak Plasma Concentration (Cmax)
From 0 to the last measurable time point t, the area under the drug time curve (AUC0-t)
Click on the lead sponsor to view all of their trials.
