NCT07259590RecruitingPhase 1/2
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
A Multicenter, Open-Label, Phase Ib/II Clinical Study to Explore the Efficacy, Pharmacokinetics and Safety/Tolerability of GFH375 in Combination With Cetuximab or Chemotherapy in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutation
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 21 Oct 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT07259590
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 126
- From 21 Oct 2025 to the primary completion date, 31 Jul 2027
- 4 sites 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
- Previous or active history of clinically significant cardiovascular dysfunction.
- Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment.
- Having received major surgery within 28 days before the start of the study treatment; having experienced major trauma within 14 days before the start of the study treatment; or planning to undergo major surgery during the study period.
- Having received radiotherapy within 4 weeks before the start of the study treatment, or having received palliative radiotherapy for bone metastatic lesions within 2 weeks before the start of the study treatment.
Other illness
- Presence of known coexisting other cancer driver genes.
- Presence of active infection.
- History of central nervous system (CNS) diseases.
- Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.
Other
- Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.
- Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.
Who the study is looking for
- Voluntarily participate in the study and sign the informed consent form.
- Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.
- Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available.
- At least one measurable lesions according to RECIST v1.1
- Participants receiving Regimen A must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 - 2; participants receiving Regimen B must have an ECOG PS score of 0 - 1.
- Have sufficient organ function.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.