NCT07262567RecruitingPhase 3
Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 4 Dec 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07262567
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 320
- From 4 Dec 2025 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignant tumors that progressed or required treatment within 3 years prior to randomization.
- 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.
- Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.
Other illness
- With clinically significant severe cardiovascular diseases.
- Complicated with major acute or chronic infectious diseases.
- Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.
- Other conditions deemed inappropriate for participation in the study by the investigator.
Other
- With active central nervous system (CNS) metastasis.
- Pregnant or lactating females.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital & Institute Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.