A Phase II Study To Evaluate GFH375 In Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer

Study Overview

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

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.

N/A

Metastatic Pancreatic Cancer

DRUG: GFH375

GFH375X1201

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-06-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-10
First Submitted that Met QC Criteria 2025-06-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-18
First Posted (ACTUAL) 2025-06-18	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: GFH375	DRUG: GFH375 GFH375 will be administered at the 600mg QD, orally, until disease progression or intolerable toxicity.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: GFH375

DRUG: GFH375

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

Primary Outcome Measures	Measure Description	Time Frame
Overall response rate (ORR)	ORR assessed by Blinded Independent Central Review	24 months

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jin Li

Phone Number: +86 21 6882 1388

Email: jli@genfleet.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record