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
Genfleet Therapeutics (Shanghai) Inc.
407 participants
Jul 9, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria7
- 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.
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Interventions
GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT06500676