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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
GIM-531
DrugGIM-531 administered orally daily
Anti-PD-1 monoclonal antibody
DrugContinued treatment with anti-PD-1 therapy
Treatment groups
117 Participants
are divided into 2 treatment groupsGroup A: Phase 1 Single AgentExperimental treatment 1 intervention
Group B: Phase 2 Combination TreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability
To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading
Time frame
Through study completion, an average of 1 year2
Dose limiting toxicities (DLT) with GIM-531
To identify dose limiting toxicities with GIM-531
Time frame
21 daysSecondary outcomes
1
Maximum plasma concentration (Cmax)
To preliminarily evaluate the Cmax in patients with advanced solid tumors
Time frame
Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose2
Time to maximum plasma concentration (Tmax)
To preliminarily evaluate Tmax in patients with advanced solid tumors
Time frame
Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose3
Area under the plasma concentration versus time curve (AUC)
To preliminarily evaluate the AUC in patients with advanced solid tumors
Time frame
Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose4
Objective response rate (ORR)
To identify objective response rate in patients with advanced solid tumors
Time frame
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov