NCT06500676
Recruiting
Phase 1
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
InterventionsGFH375
Overview
- Phase
- Phase 1
- Intervention
- GFH375
- Conditions
- KRAS G12D Mutations
- Sponsor
- Genfleet Therapeutics (Shanghai) Inc.
- Enrollment
- 407
- Locations
- 20
- Primary Endpoint
- Phase Ia:The incidence and severity of AEs and SAEs
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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-
- •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 Criteria
- •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.
Arms & Interventions
GFH375
Intervention: GFH375
Outcomes
Primary Outcomes
Phase Ia:The incidence and severity of AEs and SAEs
Time Frame: 24 months
The incidence and severity of AEs and SAEs
Phase Ia:The incidence of DLT events
Time Frame: 21 days
The incidence of DLT events
Phase Ib:The incidence and severity of AEs and SAEs
Time Frame: 24 months
The incidence and severity of AEs and SAEs
Phase II:Overall response rate (ORR)
Time Frame: 24 months
For NSCLC cohort： Assessed by BICR according to RECIST 1.1；For other cohorts： Assessed by investigators according to RECIST 1.1；
Secondary Outcomes
- Plasma concentrations(up to 21 days)
- Efficacy endpoints(24 months)
Study Sites (20)
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