A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer

Launched by GENFLEET THERAPEUTICS (SHANGHAI) INC. · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called GFH375 to see if it can help people with metastatic pancreatic cancer, a type of cancer that has spread to other parts of the body. Specifically, it focuses on patients whose cancer has a particular genetic change known as the KRAS G12D mutation. The study aims to find out how well GFH375 works, how safe it is, and how the body processes the drug.

People who might be eligible for this trial are adults between 18 and 75 years old who have this specific type of pancreatic cancer that has been confirmed by tests. They need to have at least one tumor that can be measured and be in generally good health, with a reasonable life expectancy. Participants will also need to provide tumor samples for the study. The trial is not yet enrolling patients, and those who join can expect to be closely monitored for how the treatment affects their cancer and overall health. It’s important to know that people with brain metastases, certain heart problems, active hepatitis, or who have taken similar drugs before may not be eligible. Pregnant or breastfeeding women cannot join this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• • 2. Male or female ≥ 18 years old and ≤75 years old.
• • 3. With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
• • 4. Be able to provide tumor tissue samples that meet the requirements
• • 5. Have at least one measurable lesion according to RECIST1.1
• • 6. ECOG performance status of 0-1.
• • 7. With a life expectancy of ≥12 weeks.
• • 8. Adequate laboratory parameters during the screening period.
• Exclusion Criteria:
• • 1. Active brain metastases.
• • 2. Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor.
• • 3. With poorly controlled or severe cardiovascular disease.
• • 4. Subjects with active hepatitis B or active hepatitis C.
• • 5. Known allergy to the study drug or its components.
• • 6. Pregnant or lactating women.