NCT07784374RecruitingPhase 2
A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
A Phase II, Multicenter, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of GFH375 in Combination With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Aug 2026
- Start date
- 20 Aug 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT07784374
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 20 Aug 2026 to the primary completion date, 31 Aug 2028
- 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 malignancy that has progressed or required treatment within 3 years prior to study entry.
- Prior treatment with KRAS G12D-specific or pan-RAS/KRAS targeted agents.
- Stroke or other severe cerebrovascular events within 6 months prior to randomization.
Other illness
- Clinically significant severe cardiovascular disease.
- Significant acute or chronic infectious disease.
- Severe psychiatric disorder, history of drug abuse, or significant alcohol abuse.
- Other conditions that, in the investigator's opinion, make the subject unsuitable for study participation.
Other
- Active central nervous system (CNS) metastases.
- Pregnant or lactating female subjects.
Who the study is looking for
- 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.
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 |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.