Actively Recruiting
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
Led by Georgiamune Inc · Updated on 2026-03-27
117
Participants Needed
11
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Have a confirmed diagnosis of locally advanced or metastatic solid tumor that progressed after standard therapy or lacks standard therapy, or be intolerant to standard therapy
- Not have received any experimental drug within 4 weeks or 5 half-lives prior to study treatment or be currently enrolled in another clinical study
- Have an ECOG performance status of 0 or 1
- Have acceptable cardiac, kidney, and liver function based on lab and ECG tests within 28 days before enrollment
- Agree to provide a baseline tumor biopsy or archival tumor sample from within 12 months prior to screening, or have Sponsor approval if biopsy is high risk
- For females of childbearing potential with non-sterile partners, agree to use effective contraception from 14 days before first dose until 7 months after last dose; for non-sterile males with partners of childbearing potential, agree to use barrier contraception and not donate sperm from first dose until 4 months after last dose
- Have measurable disease per RECIST version 1.1
- Phase 1 expansion specific: NSCLC patients must have locally advanced/unresectable or metastatic disease with no more than 3 prior lines of therapy; TNBC patients must have locally advanced unresectable, recurrent, or metastatic disease with no more than 3 prior lines of therapy; ovarian cancer patients must have locally advanced unresectable, recurrent, or metastatic platinum-resistant disease with no more than 1 line of therapy after platinum resistance; patients with tumors with AKT3 mutation/amplification must have locally advanced unresectable, recurrent, or metastatic solid malignancy confirmed by local NGS
- Phase 2 specific: have confirmed unresectable Stage III or metastatic Stage IV cutaneous melanoma, NSCLC, or RCC that has progressed after anti-PD-1 therapy; most recent therapy must include anti-PD-1; BRAF wild-type melanoma or RCC must have no more than 2 prior lines of therapy; BRAF mutant melanoma or NSCLC must have no more than 3 prior lines of therapy
You will not qualify if you...
- Have ongoing greater than Grade 1 toxicity from prior therapy (except Grade 2 alopecia or Grade 2 sensory neuropathy)
- Have known leptomeningeal disease, spinal cord compression, or brain metastases except if treated and stable for at least 4 weeks with no ongoing neurological symptoms and steroid use is stable or decreasing below 10 mg prednisone equivalent daily
- Have known structural heart disease or serious arrhythmias, long QT syndrome, or significant cardiac conduction abnormalities
- Have active autoimmune disease that required systemic treatment in the past 12 months (replacement therapies like thyroxine or insulin are allowed)
- Be currently receiving systemic steroids (≥10 mg/day prednisone or equivalent) or immunosuppressive therapy (topical or inhaled steroids allowed)
- Have active, clinically significant infections including hepatitis B, hepatitis C, or HIV
- Have acquired or primary immunodeficiency
- Received anti-cancer chemotherapy or immune modulating agents within 4 weeks or 5 half-lives before first dose
- Received live vaccines within 30 days prior to first dose
- Had or plan to have major surgery within 2 weeks prior to first dose
- Unable to swallow oral medication
- Taking medications that strongly affect CYP2C8, CYP3A4/5, P-glycoprotein, or breast cancer resistant protein that cannot be stopped at least 1 week before first dose and during study
- Taking drugs that alter gastric pH such as proton-pump inhibitors or H2 blockers (antacids allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Actively Recruiting
3
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
4
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, United States, 90025
Actively Recruiting
5
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, United States, 59102
Actively Recruiting
8
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
9
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
10
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
Research Team
J
Jayadev Sureddi, CBCC CRO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here