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

Recruiting now · Phase 1/Phase 2

Conditions studied: KRAS G12D Mutations, Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06500676

Run by

Genfleet Therapeutics (Shanghai) Inc.

People needed

407

Starts

2024-07-09

Expected to finish

2028-12-31

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
• Shanghai Chest Hospital — Shanhai, Shanghai Municipality, China (enrolling)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
• Harbin Medical University Cancer Hospital — Haerbin, Heilongjiang, China
• Tianjin Medical University Cancer Institute & Hospital — Tianjing, Tianjing, China
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• Sichuan Cancer Hospital — Chengdu, Sichuan, China
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China

Full record on ClinicalTrials.gov

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