Clinical Research Directory

GST101 in Participants With RAS-Mutant Advanced Solid Tumors

This is an open-label, multicenter Phase I/II trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of oral GST101 in adult participants with RAS-mutant advanced solid tumors. Phase I consists of dose escalation and dose-expansion parts. Dose escalation uses accelerated titration design combined with 3+3 design to determine maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Safety, dose-limiting-toxicity (DLT), PK and preliminary efficacy will be assessed. Phase II (indication-exploration) enrolls participants in four tumor-specific cohorts including RAS-mutant NSCLC, colorectal cancer, pancreatic ductal adenocarcinoma and other advanced solid tumors refractory to standard-of-care therapies. Participants receive GST101 orally once-daily in 21-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or loss of clinical benefit. Tumor assessments follow RECIST 1.1. Safety, PK, QTc and exploratory biomarker analyses will be performed.