Clinical trialPhase 1 / Phase 2Recruiting
GST101 in Participants With RAS-Mutant Advanced Solid Tumors
A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GST101 in Participants With RAS-Mutant Advanced Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 30 October 2026
- Expected end
- October 2028
- Enrollment
- 172 participants
- Sites
- 8
- Primary outcomes
- Number of Participants with Dose-Limiting Toxicity (DLT); Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs; Maximum Tolerated Dose (MTD); Recommended Phase 2 Dose (RP2D); Objective Response Rate (ORR)
- Sponsor
- Industry
- Results posted
- No
- Last update
- 6 November 2026
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Brief summary public domain (ClinicalTrials.gov)
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.