NCT06425926 · Georgiamune Inc
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
What this study is about
GIM-531 is a first-in-class, taken by mouth 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).
View original scientific description
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).
Interventions
DRUG
GIM-531
GIM-531 administered orally daily
DRUG
Anti-PD-1 monoclonal antibody
Continued treatment with anti-PD-1 therapy
Primary outcome measures
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability
Time frame: Through 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-531
Time frame: 21 days
To identify dose limiting toxicities with GIM-531
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 contraceptio
Where
- Scottsdale, Arizona
- Bakersfield, California
- Fullerton, California
- Los Angeles, California
- San Francisco, California
- Boston, Massachusetts
- Billings, Montana
- New York, New York
- Cincinnati, Ohio
- Nashville, Tennessee
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations