Actively Recruiting
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
Led by Genfleet Therapeutics (Shanghai) Inc. · Updated on 2025-11-20
407
Participants Needed
20
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
CONDITIONS
Official Title
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 75 years
- ECOG performance status of 0-1
- Life expectancy of at least 12 weeks
- Histologically or cytologically confirmed advanced or metastatic solid tumors with KRAS G12D mutation
- At least one measurable lesion according to RECIST 1.1 (Phase Ia allows no measurable lesion)
- Adequate laboratory parameters during screening
You will not qualify if you...
- Active brain metastases
- Prior treatment with a KRAS G12D inhibitor
- Completed palliative radiotherapy within 14 days before first dose
- Poorly controlled or severe cardiovascular disease
- Active hepatitis B or active hepatitis C
- Known allergy to the study drug or its components
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
2
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
5
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Not Yet Recruiting
7
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
Not Yet Recruiting
8
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
9
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
10
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
11
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
12
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Not Yet Recruiting
13
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
14
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
15
Shanghai Chest Hospital
Shanhai, Shanghai Municipality, China, 201210
Actively Recruiting
16
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
17
Tianjin Medical University Cancer Institute & Hospital
Tianjing, Tianjing, China
Not Yet Recruiting
18
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
19
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
20
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yolanda Zeng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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