A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors
Trial Parameters
Brief Summary
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
Eligibility Criteria
Inclusion Criteria: * 1\. Patients should understand, sign, and date the written informed consent form before screening. * 2\. Male or female aged 18 years or older. * 3\. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type. * 4\. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing. * 5\. Patients should provide archival tumor sample or undergo tumor biopsy at baseline if archival sample is not available or inadequate. * 6\. Backfill cohorts and expansion cohorts: Patients with 1 of the following cancers and have received no more than 3 prior lines of therapy。1)NSCLC；2) Pancreatic cancer；3)Esophageal cancer；4)Gastric c