Actively Recruiting
An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 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
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GFH375 in adults with advanced solid tumors that have a KRAS G12D mutation. This open-label, phase I/II clinical trial aims to explore the safety, tolerability, how the body processes the drug, and early signs of effectiveness in this patient group. Participants will receive GFH375 orally at assigned dose levels and continue treatment until their disease progresses or they experience unacceptable side effects. The study has multiple phases: phase Ia focuses on safety and dose-limiting toxicities over 21 days and up to 24 months, phase Ib also monitors safety for up to 24 months, and phase II assesses overall tumor response over 24 months. During the trial, participants will undergo regular assessments including monitoring for adverse events, blood tests for drug levels, and tumor measurements using RECIST 1.1 criteria. The main outcomes measured are the frequency and severity of side effects, dose-limiting toxicities, and tumor response rate. The total participation can last up to 24 months with detailed safety and efficacy evaluations throughout.
CONDITIONS
Brief 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...
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female 18 years old and 75 years old or younger.
- ECOG performance status of 0-1.
- With a life expectancy of 12 weeks or more.
- Histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
- Have at least one measurable lesion according to RECIST1.1, phase Ia allows no measurable lesion.
- Adequate laboratory parameters during the screening period.
You will not qualify if you...
- Active brain metastases.
- Prior treatment with a KRAS G12D inhibitor.
- Palliative radiotherapy completed 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or intolerable toxicity
Participants receive the study drug GFH375 orally at the assigned dose level until disease progression or intolerable toxicity.
Visits occur as needed for dosing and safety monitoring
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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