NCT07026916

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
28mo left

Started Aug 2025

Typical duration for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Aug 2025Aug 2028

First Submitted

Initial submission to the registry

June 3, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

June 3, 2025

Last Update Submit

November 14, 2025

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    ORR assessed by Blinded Independent Central Review

    24 months

Secondary Outcomes (7)

  • ORR

    24 months

  • DCR

    24 months

  • DoR

    24 months

  • TTR

    24 months

  • PFS

    24 months

  • +2 more secondary outcomes

Study Arms (1)

GFH375

EXPERIMENTAL
Drug: GFH375

Interventions

GFH375DRUG

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

GFH375

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
  • Be able to provide tumor tissue samples that meet the requirements
  • Have at least one measurable lesion according to RECIST1.1
  • ECOG performance status of 0-1.
  • With a life expectancy of ≥12 weeks.
  • Adequate laboratory parameters during the screening period.

You may not qualify if:

  • Active brain metastases.
  • Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor.
  • With 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 18, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share