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
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 agree to participate and sign informed consent.
- For Regimen A, be 18 years or older; for Regimen B, be between 18 and 75 years old.
- 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 per RECIST v1.1.
- For Regimen A, have an ECOG performance status of 0 to 2; for Regimen B, ECOG performance status of 0 to 1.
- Have sufficient organ function.
You will not qualify if you...
- Have symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.
- Have known coexisting cancer driver genes.
- Have a history of clinically significant cardiovascular dysfunction.
- Have an active infection.
- Have a history of central nervous system diseases.
- Have clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.
- Have newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before treatment.
- Have uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.
- Have had major surgery within 28 days or major trauma within 14 days before starting treatment, or plan major surgery during the study.
- Have had radiotherapy within 4 weeks before treatment or palliative radiotherapy for bone metastases within 2 weeks before treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Junnan Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here