Status:
NOT_YET_RECRUITING
A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors
Lead Sponsor:
Genfleet Therapeutics (Shanghai) Inc.
Conditions:
Cancer
PDAC
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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 ≥3 moths
- 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 PAN-RAS 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 :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT07198321
Start Date
September 22 2025
End Date
December 30 2027
Last Update
September 30 2025
Active Locations (1)
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1
Sun-Yat sen university cancer center
Guangzhou, Guangdong, China, 510000