NCT07262567 Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
| NCT ID | NCT07262567 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Genfleet Therapeutics (Shanghai) Inc. |
| Condition | Metastatic Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 320 participants in total. It began in 2025-12-04 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07262567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Metastatic Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07262567 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 320 participants.
Is NCT07262567 currently recruiting?
Yes, NCT07262567 is actively recruiting participants. Contact the research team at jli@genfleet.com for enrollment information.
Where is the NCT07262567 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07262567 clinical trial?
NCT07262567 is sponsored by Genfleet Therapeutics (Shanghai) Inc.. The trial plans to enroll 320 participants.
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