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Trial Title:
A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
NCT ID:
NCT06500676
Condition:
KRAS G12D Mutations
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GFH375
Description:
GFH375 will be administered at the assigned dose level, orally, until disease progression
or intolerable toxicity.
Arm group label:
GFH375
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must voluntarily agree to participate in the trial and sign a written
informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. With a life expectancy of ≥12 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanhai
Zip:
201210
Country:
China
Status:
Recruiting
Contact:
Last name:
Shun Lu, MD
Start date:
July 9, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Genfleet Therapeutics (Shanghai) Inc.
Agency class:
Industry
Source:
Genfleet Therapeutics (Shanghai) Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500676
