Status:
RECRUITING
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
Lead Sponsor:
Genfleet Therapeutics (Shanghai) Inc.
Conditions:
KRAS G12D Mutations
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 KR...
Eligibility Criteria
Inclusion
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female ≥ 18 years old and ≤75 years old.
- ECOG performance status of 0-1.
- With a life expectancy of ≥12 weeks.
- With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
- Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
- Adequate laboratory parameters during the screening period.
Exclusion
- Active brain metastases.
- Prior treatment with a KRAS G12D inhibitor.
- Palliative radiotherapy was completed within 14 days before the first dose.
- Have poorly controlled or severe cardiovascular disease.
- Subjects with active hepatitis B or active hepatitis C.
- Known allergy to the study drug or its components.
- Pregnant or lactating women.
Key Trial Info
Start Date :
July 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT06500676
Start Date
July 9 2024
End Date
December 31 2028
Last Update
November 20 2025
Active Locations (20)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
2
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
4
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China