A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
NCT ID: NCT06500676
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
407 participants
INTERVENTIONAL
2024-07-09
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GFH375
GFH375
GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Interventions
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GFH375
GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Genfleet Therapeutics (Shanghai) Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shun Lu, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Aiping Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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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, 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
Countries
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Central Contacts
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Facility Contacts
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jianbo he
Role: backup
Zuoxin Niu
Role: backup
Other Identifiers
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GFH375X1101
Identifier Type: -
Identifier Source: org_study_id
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