NCT06500676

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

An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 407 (estimated)
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• KRAS G12D Mutations
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GFH375	GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Timeline

• Start date: 2024-07-09
• Primary completion: 2028-07-31
• Completion: 2028-12-31
• First posted: 2024-07-15
• Last updated: 2025-11-20

Locations

20 sites across 1 country: China