A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
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
1 other identifier
interventional
407
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2024
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2024
CompletedStudy Start
First participant enrolled
July 9, 2024
CompletedFirst Posted
Study publicly available on registry
July 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
November 20, 2025
November 1, 2025
4.1 years
July 8, 2024
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Phase Ia:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
24 months
Phase Ia:The incidence of DLT events
The incidence of DLT events
21 days
Phase Ib:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
24 months
Phase II:Overall response rate (ORR)
For NSCLC cohort： Assessed by BICR according to RECIST 1.1；For other cohorts： Assessed by investigators according to RECIST 1.1；
24 months
Secondary Outcomes (5)
Plasma concentrations
up to 21 days
Efficacy endpoints
24 months
Efficacy endpoints
24 months
Efficacy endpoints
24 months
Efficacy endpoints
24 months
Study Arms (1)
GFH375
EXPERIMENTALInterventions
GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 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
Jiangsu Province Hospital
Nanjing, Jiangsu, 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 Municipality, 201210, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjing, Tianjing, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Study Officials
- PRINCIPAL INVESTIGATOR
Shun Lu, MD
Shanghai Chest Hospital
- PRINCIPAL INVESTIGATOR
Aiping Zhou, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2024
First Posted
July 15, 2024
Study Start
July 9, 2024
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share