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โ† Trials
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A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllGenfleet Therapeutics (Shanghai) Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female โ‰ฅ 18 years old and โ‰ค75 years old. 3. ECOG performance status of 0-1. 4. With a life expectancy of โ‰ฅ12 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.
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What it tests

  • GFH375
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Where

20 sites
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Guangxi Medical University Cancer Hospital
Nanning, China
Harbin Medical University Cancer Hospital
Haerbin, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China

โ€ฆand 12 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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