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

Official record

Identifier

NCT07262567

Recruiting locations

country

China

Interventions studied

GFH375Chemotherapy

Lead sponsor

Genfleet Therapeutics (Shanghai) Inc.

Target enrolment

320 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Dec 3, 2025

Last updated on the registry

Aug 14, 2026

Age

18 Years – 80 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Pancreatic Cancer