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

GenFleet Therapeutics

Status and phase: Begins enrollment this month; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: GFH375

Study type: Interventional

Funder types: Industry

Identifiers

NCT07026916

GFH375X1201

Details and patient eligibility

About

This is a multicenter, open-label, phase II study to explore the efficacy, safety/tolerability and pharmacokinetics (PK) of GFH375 in in Patients with Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer.

Enrollment: 83 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

GFH375

Experimental group

Treatment:

Drug: GFH375