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

A Single-Arm, Multicenter, Open-Label, Phase II Clinical Study to Evaluate the Efficacy, Safety/Tolerability, and Pharmacokinetic Characteristics of GFH375 Monotherapy in Patients With Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07026916

Enrollment

Registered

2025-06-18

Start date

2025-08-31

Completion date

2028-08-31

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Cancer

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.

Interventions

DRUGGFH375

GFH375 will be administered at the 600mg QD, orally, until disease progression or intolerable toxicity.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall response rate (ORR)	24 months	ORR assessed by Blinded Independent Central Review

Secondary

Measure	Time frame	Description
DCR	24 months	Disease control rate (DCR)
DoR	24 months	Duration of Response (DoR)
TTR	24 months	Time to Response(TTR)
ORR	24 months	ORR assessed by investigators
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
PFS	24 months	Progression Free Survival (PFS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026