A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

Phase 1

Recruiting

• Conditions: KRAS G12D Mutations; Advanced Solid Tumors
• Interventions: Drug: GFH375

• 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

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study Start: 2024-07-09
• Study First Posted: 2024-07-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2028-07-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. With a life expectancy of ≥12 weeks.
5. With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
7. Adequate laboratory parameters during the screening period.

Exclusion Criteria

1. Active brain metastases.
2. Prior treatment with a KRAS G12D inhibitor.
3. Palliative radiotherapy was completed within 14 days before the first dose.
4. Have poorly controlled or severe cardiovascular disease.
5. Subjects with active hepatitis B or active hepatitis C.
6. Known allergy to the study drug or its components.
7. 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