Actively Recruiting
Study of GFH375 to Evaluate Safety and Effects in Patients With KRAS G12D Mutant Advanced Solid Tumors
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
Researchers are conducting a multicenter, open-label phase I/II study to evaluate the safety, tolerability, pharmacokinetics, and early efficacy of the drug GFH375 in patients with advanced solid tumors that have a KRAS G12D mutation. This mutation is a key focus, and the study includes adults aged 18 to 75 years who have confirmed advanced or metastatic solid tumors with this specific genetic change. Participants will receive GFH375 orally at assigned dose levels and continue treatment until their disease progresses or they experience intolerable side effects. The study includes multiple phases: Phase Ia and Ib focus on safety and drug tolerability over 24 months, monitoring adverse events and dose-limiting toxicities, while Phase II evaluates the overall response rate over the same period. Throughout the study, patients will undergo regular assessments including laboratory tests and imaging to measure tumor response. Safety will be closely monitored by tracking adverse events and serious adverse events. The total duration of participation includes long-term follow-up of up to 24 months to assess both safety and treatment efficacy.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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