Actively Recruiting
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
Led by Genfleet Therapeutics (Shanghai) Inc. · Updated on 2025-12-02
126
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, effectiveness, and how the body processes two combination treatments involving GFH375 for people with advanced solid tumors that have the KRAS G12D mutation. This Phase Ib/II study explores Regimen A, which combines GFH375 with Cetuximab, and Regimen B, which combines GFH375 with chemotherapy (AG). The study aims to understand both the safety and potential benefits of these therapies and to explore links between biomarkers and clinical outcomes. Participants in Arm A receive GFH375 every day along with Cetuximab given through an intravenous infusion every two weeks. Arm B participants receive GFH375 daily combined with chemotherapy drugs paclitaxel (albumin-bound) and gemcitabine administered intravenously on Days 1, 8, and 15 of each 4-week cycle. Arm A enrolls people with various advanced solid tumors with the KRAS G12D mutation, while Arm B focuses on those with pancreatic ductal adenocarcinoma (PDAC) featuring the same mutation. During the study, participants are monitored for side effects, dose-limiting toxicities, and treatment responses using imaging criteria (RECIST 1.1). Blood tests will measure GFH375 levels, and safety is assessed from the first dose until 30 days after the last dose, with follow-up lasting up to 24 months. Outcomes like tumor response rate, disease control, progression-free survival, and overall survival are evaluated. This research helps understand how well the treatments work and their safety in people with these cancers.
CONDITIONS
Brief Title
A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign informed consent.
- Be 18 years or older for Regimen A; 18 to 75 years old for Regimen B.
- Have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12D mutation.
- Have failed, be intolerant to, unsuitable for, or have no available standard systemic treatment.
- Have at least one measurable lesion by RECIST v1.1.
- ECOG Performance Status score of 0 to 2 for Regimen A; 0 to 1 for Regimen B.
- Have sufficient organ function.
You will not qualify if you...
- Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.
- Known coexisting other cancer driver genes.
- Previous or active significant cardiovascular dysfunction.
- Active infection.
- History of central nervous system diseases.
- Clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.
- Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before study treatment.
- Uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.
- Major surgery within 28 days or major trauma within 14 days before study treatment, or planned major surgery during the study.
- Radiotherapy within 4 weeks before study treatment, or palliative radiotherapy for bone metastases within 2 weeks before study treatment.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or discontinuation
Participants receive GFH375 combined with either Cetuximab or chemotherapy. Cetuximab is given intravenously every 2 weeks, and chemotherapy is administered on Days 1, 8, and 15 of each 4-week cycle while taking GFH375 daily.
Visits every 1 to 2 weeks depending on treatment schedule
Duration - 30 days after the last dose, with assessments up to 24 months
Participants are monitored for safety and treatment effects after the last dose, including adverse events and disease progression.
Periodic visits up to 24 months
Trial Site Locations
Total: 4 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
Research Team
Y
Yolanda Zeng
J
Junnan Dong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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