Clinical trialPhase 1 / Phase 2Not yet recruiting
A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors
A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 22 September 2025
- Expected end
- 30 December 2027
- Enrollment
- 450 participants
- Sites
- 1
- Primary outcomes
- Phase Ia:The incidence and severity of AEs and SAEs; Phase Ia:The incidence of DLT events; Phase Ib:The incidence and severity of AEs and SAEs; Phase II:Overall response rate (ORR); Efficacy endpoints
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 30 September 2025
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Source text
Brief summary public domain (ClinicalTrials.gov)
This study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations. The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276. The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.