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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Usage and dosage: 25mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 50mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 75mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 100mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Usage and dosage: 125mg, oral on an empty stomach Duration of medication: oral once a day, 21 days as a cycle
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAdverse 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.
Time frame: Up to 2 years
Serious Adverse Event (SAE)
Time frame: Up to 2 years
Adverse Events of Special Concern (AESI)
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
Disease Control Rate (DCR)
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.
Time frame: Up to 2 years
Duration of Relief (DOR)
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.
Time frame: Up to 2 years
Progression free survival (PFS)
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).
Time frame: Up to 2 years
Overall survival (OS)
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.
Time frame: Up to 2 years
Peak Time (Tmax)
Time frame: Up to 2 years
Peak Plasma Concentration (Cmax)
Time frame: Up to 2 years
From 0 to the last measurable time point t, the area under the drug time curve (AUC0-t)
Time frame: Up to 2 years
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.