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

Phase 2

Not yet recruiting

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: GFH375

• Registration Number: NCT07026916
• Lead Sponsor: Genfleet Therapeutics (Shanghai) Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-18
• Last Update Posted: 2025-06-18
• Study Start: 2025-08-01
• Primary Completion: 2027-12-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GFH375	GFH375	-

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	24 months	ORR assessed by Blinded Independent Central Review

Secondary Outcome Measures

Name	Time	Method
ORR	24 months	ORR assessed by investigators
DCR	24 months	Disease control rate (DCR)
DoR	24 months	Duration of Response (DoR)
TTR	24 months	Time to Response(TTR)
PFS	24 months	Progression Free Survival (PFS)
The incidence and severity of AEs and SAEs	24 months	The incidence and severity of AEs and SAEs
Plasma concentrations of GFH375	6 months	Plasma concentrations of GFH375