A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
- Registration Number
- NCT06500676
- Lead Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 390
- 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.
- ECOG performance status of 0-1.
- With a life expectancy of ≥12 weeks.
- With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
- Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
- Adequate laboratory parameters during the screening period.
- Active brain metastases.
- Prior treatment with a KRAS G12D inhibitor.
- Palliative radiotherapy was completed within 14 days before the first dose.
- Have poorly controlled or severe cardiovascular disease.
- Subjects with active hepatitis B or active hepatitis C.
- Known allergy to the study drug or its components.
- Pregnant or lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GFH375 GFH375 -
- Primary Outcome Measures
Name Time Method Phase Ib:The incidence and severity of AEs and SAEs 24 months The incidence and severity of AEs and SAEs
Phase Ia:The incidence and severity of AEs and SAEs 24 months The incidence and severity of AEs and SAEs
Phase Ia:The incidence of DLT events 21 days The incidence of DLT events
Phase II:Overall response rate (ORR) 24 months Aassessed by investigators according to RECIST 1.1
- Secondary Outcome Measures
Name Time Method Plasma concentrations up to 21 days Plasma concentrations and PK parameters of GFH375
Efficacy endpoints 24 months Overall survival (OS)
Trial Locations
- Locations (20)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
🇨🇳Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Shanghai Chest Hospital
🇨🇳Shanhai, Shanghai, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjing, Tianjing, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hang Zhou, Zhejiang, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China