Clinical trialPhase 1 / Phase 2Recruiting
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
A Multicenter, Open-Label, Phase Ib/II Clinical Study to Explore the Efficacy, Pharmacokinetics and Safety/Tolerability of GFH375 in Combination With Cetuximab or Chemotherapy in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutation
- Outcome
- Ongoing
- Phase
- Phase 1 / Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 21 October 2025
- Expected end
- July 2027
- Enrollment
- 126 participants
- Sites
- 4
- Primary outcomes
- Phase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events; Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE); Phase II: Objective Response Rate (ORR) Evaluated by RECIST 1.1
- Sponsor
- Industry
- Results posted
- No
- Last update
- 2 December 2025
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Brief summary public domain (ClinicalTrials.gov)
This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.