GFH375 plus chemotherapy in KRAS G12D-mutant metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study enrolls adults with metastatic pancreatic cancer carrying the KRAS G12D mutation who have progressed after at least one prior systemic therapy. Participants are randomly assigned in a 1:1 ratio to receive GFH375 plus chemotherapy or chemotherapy alone. Eligibility requires measurable disease, adequate organ function, and an expected survival of at least 12 weeks. Exclusion criteria include other active cancers, CNS metastases, prior KRAS G12D-targeted therapy, recent radiotherapy, and recent anti-tumor treatments. The trial is led by Genfleet Therapeutics (Shanghai) with a site at Peking University Cancer Hospital & Institute in Beijing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Cancer Hospital & Institute
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jin Li
• Email: jli@genfleet.com
• Phone: +86 21 6882 1388

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.