Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer

NCT ID: NCT07262567

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-06-30

Brief Summary

This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.

Conditions

Metastatic Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GFH375

GFH375, Oral tablets

Group Type: EXPERIMENTAL

GFH375

Intervention Type: DRUG

The experimental group receives GFH375 monotherapy, QD, orally

Chemotherapy

There are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator.

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator.

Interventions

GFH375

The experimental group receives GFH375 monotherapy, QD, orally

Intervention Type: DRUG

Chemotherapy

The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator.

Intervention Type: DRUG

Other Intervention Names

Irinotecan Hydrochloride Liposome Injection; Fluorouracil Injection; Calcium Folinate; Tegafur,Gimeracil and Oteracil Potassium Capsules; Gemcitabine Hydrochloride for Injection; Paclitaxel for Injection(Albumin Bound)

Eligibility Criteria

Inclusion Criteria

• Voluntarily participate in the study and sign the informed consent form.
• Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.
• Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.
• Have received at least one prior standard systemic therapy.
• Participants must have at least one measurable lesion (per RECIST 1.1 criteria).
• Expected survival time ≥ 12 weeks as judged by the investigator.
• Have adequate organ function

Exclusion Criteria

• Other malignant tumors that progressed or required treatment within 3 years prior to randomization.
• With active central nervous system (CNS) metastasis.
• Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.
• Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.
• Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.
• With clinically significant severe cardiovascular diseases.
• Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.
• Complicated with major acute or chronic infectious diseases.
• Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.
• Pregnant or lactating females.
• Other conditions deemed inappropriate for participation in the study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genfleet Therapeutics (Shanghai) Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jin Li

Role: CONTACT

jli@genfleet.com

+86 21 6882 1388

Other Identifiers

GFH375X1301

Identifier Type: -

Identifier Source: org_study_id