A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGenfleet Therapeutics (Shanghai) Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GFH375
Treatment groups
407 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov