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GST101 in RAS-Mutant Advanced Solid Tumors
NCT07868172Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2026
- Primary completion
- Oct 2028
- Countries
- 1
- Sponsor
- SEED Therapeutics
- Drugs
- GST101
- Conditions
- solid tumornon-small cell lung cancer (NSCLC)colorectal cancer (CRC)pancreatic cancer (PC)
01
Overview
Phase 2, open-label, single-arm trial of GST101 in solid tumor, non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and 1 more, sponsored by SEED Therapeutics. Primary endpoints: Dose-Limiting Toxicity at 21 days, Treatment-Emergent Adverse Events and Serious Adverse Events at 36 months and 3 more. Planned start Oct 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
GST101 Monotherapy
Participants receive oral GST101 once-daily in 21-day treatment cycles. Multiple dose levels (10 mg to 100 mg) evaluated in Phase I, followed by RP2D in Phase II.
03
Who it enrols
Adults with RAS-mutated advanced solid tumors (including NSCLC, CRC, pancreatic cancer) who have progressed on or are intolerant to standard therapies, with ECOG 0-1 and adequate organ function.
04
Endpoints
Primary
Dose-Limiting Toxicity
Treatment-Emergent Adverse Events and Serious Adverse Events
Maximum Tolerated Dose
Recommended Phase 2 Dose
Objective Response Rate
Secondary
Duration of Response
Disease Control Rate
Progression-Free Survival
Overall Survival
Maximum Observed Blood Concentration
Time to Reach Maximum Blood Concentration
Area Under the Concentration-time Curve
Elimination Half-Life
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