Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorgiamune Inc
About this trial
GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs).
Eligibility criteria
Qualifiers
Written informed consent
Cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard therapy exist; or be intolerant of standard therapy
Have not received an experimental drug within 4 weeks or 5 half-lives (whichever is shorter) of study drug treatment or already be enrolled in a clinical study
ECOG performance status 0-1
Disqualifiers
Ongoing >Grade 1 toxicity from prior therapy according to Common Terminology Criteria for Adverse Events v5.0 (Note: Grade 2 alopecia and Grade 2 sensory neuropathy are not exclusionary)
Brain metastases that have been treated and are clinically stable for at least 4 weeks prior to the first administration of study drug; Note: Participants receiving steroids for brain metastases must be either off steroids or on a stable, or decreasing dose, of <10 mg daily of prednisone (or equivalent) in order to be eligible for enrollment; and
No ongoing neurological symptoms related to the anatomic location of the brain metastases.
Has known structural cardiac disease
Trial design
Treatments tested in this trial
- GIM-531
- Anti-PD-1 monoclonal antibody
Treatment groups
117 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov