A Phase II Study to Evaluate GFH375 in Patients With KRAS G12D Mutant Metastatic Pancreatic Cancer
NCT ID: NCT07026916
Last Updated: 2025-11-17
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2025-08-31
2028-08-31
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 600mg QD, orally, until disease progression or intolerable toxicity.
Interventions
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GFH375
GFH375 will be administered at the 600mg QD, 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. With histologically or cytologically confirmed metastatic pancreatic cancer harboring KRAS G12D mutation
4. Be able to provide tumor tissue samples that meet the requirements
5. Have at least one measurable lesion according to RECIST1.1
6. ECOG performance status of 0-1.
7. With a life expectancy of ≥12 weeks.
8. Adequate laboratory parameters during the screening period.
Exclusion Criteria
2. Prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor.
3. With poorly controlled or severe cardiovascular disease.
4. Subjects with active hepatitis B or active hepatitis C.
5. Known allergy to the study drug or its components.
6. 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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Other Identifiers
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GFH375X1201
Identifier Type: -
Identifier Source: org_study_id
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