GIM-531 for Advanced Solid Tumors and Melanoma
This study is testing GIM-531, a new oral medication, for people with advanced solid tumors or melanoma that has progressed after other treatments. GIM-531 works by targeting regulatory T-cells (Tregs), which are immune cells. The study aims to find out how safe GIM-531 is and what side effects it might cause, especially when given alone or with an anti-PD-1 monoclonal antibody (a type of immunotherapy). You might be able to join if you are 18 or older, have a solid tumor or melanoma that has progressed, and meet other specific criteria. The study is currently recruiting about 117 participants, but its overall status is unclear.
- Study design
- This is a Phase 1/2, open-label (meaning you and your doctors will know what treatment you are receiving) study. It will involve a dose escalation to find the right amount of GIM-531, followed by an expansion phase.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects and tolerability through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06425926
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentGeorgiamune Inc
~117 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:GIM-531Anti-PD-1 monoclonal antibody
At a glance
Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability
Measured over Through study completion, an average of 1 year
+1 more outcome measured
Conditions
Where it's being run
11 sites across 8 statesCalifornia4
Arizona1
Massachusetts1
Montana1
New York1
Ohio1
Tennessee1
Virginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions
Agree to baseline core needle biopsy or archival (within 12 months of screening) tumor submission; Note: Participants whose only site(s) of disease are in areas considered moderate or high risk for biopsy complications may be enrolled without a fresh biopsy upon Sponsor approval.
Non pregnant participants; female participants of child bearing potential with non-sterile partners agree to use an effective form of contraception from the time of first dose of study drug (or 14 days prior to first dose for oral contraception) until 7 months after the last dose of study drug. Effective forms of contraception include hormonal (injection or oral), double barrier method, or intrauterine device. Non-sterile male participants with sexual partners of childbearing potential agree to use a barrier contraception method and agree to not donate sperm from the time of first dose of study drug until 4 months after the last dose of study drug.
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
NSCLC: Participants must have locally advanced/unresectable or metastatic NSCLC. Participants must have received no more than 3 prior lines of therapy in the advanced/metastatic setting.
TNBC: Participants must have locally advanced unresectable, recurrent, or metastatic TNBC. Participants must have received no more than 3 prior lines of therapy in the advanced/metastatic setting.
Ovarian Cancer: Participants must have locally advanced unresectable, recurrent, or metastatic ovarian cancer. Participants must have platinum-resistant ovarian cancer defined as disease recurrence or within 6 months after the last administration of platinum-based chemotherapy. Participants must have received no more than 1 line of therapy after development of platinum resistance. Maintenance treatment with Poly(ADP-ribose) polymerase inhibitors (PARPi) or bevacizumab are not counted as separate lines of therapy.
Tumors with AKT3 mutation/amplification: Participants must have a locally advanced unresectable, recurrent, or metastatic solid malignancy. Participants with known AKT3 mutation/amplification based on next generation sequencing (NGS) performed per local standard of care.
Have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma, NSCLC, or RCC that has radiographically progressed (as confirmed by imaging assessed by the Investigator) on an approved single-agent or combination anti-PD-1 therapy
Must have received the anti-PD-1 therapy containing regimen as the latest line of treatment and be eligible to restart or to continue anti-PD-1 therapy in combination with GIM-531
BRAF wild-type melanoma or RCC: Participants must have received no more than 2 prior lines of therapy in the advanced/metastatic setting
BRAF (V600) mutant melanoma or NSCLC: Participants must have received no more than 3 prior lines of therapy in the advanced/metastatic setting.
Exclusion
Has known leptomeningeal disease, spinal cord compression, or brain metastases, except participants with the following:
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
Has known serious arrythmia, serious dysrhythmia, history of long QT syndrome, or clinically relevant cardiac conduction abnormalities
Has an active autoimmune disease that has required systemic treatment in the past 12 months (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
At time of screening, is receiving systemic steroid therapy (greater than or equal to 10 mg/day of prednisone or equivalent) or is taking any immunosuppressive therapy; Note: Use of topical, inhaled, nasal, or ophthalmic steroids is allowed.
Has active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Has a history of, or currently has, an acquired or primary (congenital) immunodeficiency;
Has had prior anti-cancer treatment with chemotherapeutic agents or immune modulating agents within \<4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study drug.
Has received a live vaccine within 30 days of first dose of study drug;
Has had or has planned major surgery within 2 weeks of the first dose of study drug;
Inability to swallow an oral dose of a medication (eg, oral capsules)
Is taking medications that are considered strong inducers or inhibitors of CYP2C8 or CYP3A4/5, P-glycoprotein (P-gp), breast cancer resistant protein (BCRP), or sensitive substrates of P-gp and BCRP (Appendix C) that cannot be discontinued at least 1 week prior to first dose of study drug and for the duration of the study.
Is taking drugs that modify gastric pH, such as proton-pump inhibitors (PPIs) or H2 blockers. Antacids such as calcium carbonate or aluminum hydroxide-based products are permitted.
What this trial measures
- Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerabilityThrough study completion, an average of 1 year
To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading
- Dose limiting toxicities (DLT) with GIM-53121 days
To identify dose limiting toxicities with GIM-531