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Small Molecule

GIM-531 for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Georgiamune Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
ECOG performance status 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Awards & highlights

Summary

"This trial is testing a new drug called GIM-531 for the treatment of advanced solid tumors. The drug works by targeting and inhibiting regulatory T-cells that play a role in the growth of

Who is the study for?
This trial is for adults with advanced solid tumors, including melanoma, that have worsened after standard treatment or who can't tolerate it. They must not have taken experimental drugs recently and should be in good physical condition (ECOG 0-1). Participants need functioning major organs and agree to a tumor biopsy. Women of childbearing age and men must use effective contraception.
What is being tested?
The study tests GIM-531, an oral drug designed to block certain immune cells (Tregs) that may allow tumors to grow. It's given as a single agent or rescue therapy for those whose cancer has progressed on anti-PD-1 therapy, which they will continue during the trial.
What are the potential side effects?
Potential side effects are not explicitly listed but could include typical reactions associated with immunotherapy such as fatigue, skin reactions, digestive issues, liver problems, inflammation in various organs and potential impact on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has worsened despite treatment, or there's no treatment that works for me.
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I am fully active or can carry out light work.
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My melanoma cannot be surgically removed and has worsened on anti-PD-1 therapy.
Select...
I am currently on my first round of anti-PD-1 therapy and can continue it during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities (DLT) with GIM-531
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Best overall response (BOR)
Disease control rate (DCR)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 Combination TreatmentExperimental Treatment2 Interventions
GIM-531 administered orally daily in combination with anti-PD-1 therapy
Group II: Phase 1 Single AgentExperimental Treatment1 Intervention
GIM-531 administered orally daily

Find a Location

Who is running the clinical trial?

Georgiamune IncLead Sponsor
2 Previous Clinical Trials
175 Total Patients Enrolled
~56 spots leftby Dec 2025
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