GFH375 plus GFH276 or GFH202A vs GFH375 alone in KRAS G12D 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 is a randomized phase II trial enrolling adults with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D who have received at least one prior systemic therapy. Participants will receive GFH375 alone or in combination with GFH276 or GFS202A to compare anti-tumor activity and effects on body weight. The study uses RECIST 1.1 to measure measurable lesions and will monitor safety and organ function. Primary goals are to assess efficacy differences between combination therapy and monotherapy, with secondary observations on tolerability and weight impact. Conducted at Ruijin Hospital in Shanghai, the trial is sponsored by Genfleet Therapeutics (Shanghai) Inc.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Able to provide written informed consent prior to any study-related procedures.
* Male or female subjects aged between 18 and 80 years (inclusive) at the time of informed consent.
* Histologically or cytologically confirmed pancreatic adenocarcinoma.
* Estimated life expectancy ≥ 3 months as judged by the investigator.
* Has received at least 1 prior line of systemic anti-tumor therapy.
* Has at least one measurable lesion per RECIST version 1.1.
* Adequate organ function.

Exclusion Criteria:

* Other malignancy that has progressed or required treatment within 3 years prior to study entry.
* Active central nervous system (CNS) metastases.
* Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents.
* Clinically significant severe cardiovascular disease.
* Stroke or other severe cerebrovascular events within 6 months prior to randomization.
* Significant acute or chronic infectious disease.
* Severe psychiatric disorder, history of drug abuse, or significant alcohol abuse.
* Pregnant or lactating female subjects.
* Other conditions that, in the investigator's opinion, make the subject unsuitable for study participation.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Lizhi Yi +86 21 6882 1388
• Email: lzyi@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.