Clinical Trial

A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

Recruiting Phase 1/2
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Summary
This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-07-08; most recent amendment 2025-11-17.
Status change: Not Yet Recruiting → Recruiting 2024-07-15
Trial Details
NCT Number NCT06500676
Lead Sponsor Genfleet Therapeutics (Shanghai) Inc.
Conditions KRAS G12D Mutations, Advanced Solid Tumors
Enrollment 407 participants
Start Date 2024-07-09
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-20