Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors

March 25, 2026 updated by: Georgiamune Inc

A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

GIM531-CT01 is a Phase 1/2 open label, first-in-human, multicenter study. The Phase 1 portion will include a dose escalation with GIM-531 administered as a single agent. Additionally, there will be a dose expansion portion at the safety-cleared dose levels with participants allocated 1:1 within the proposed therapeutic range to accrue additional data for determining the safety profile, pharmacokinetics (PK) profile, pharmacodynamic (PD) effects and early anti-tumor activity of GIM-531. In Phase 2, GIM-531will be administered to participants with advanced/metastatic cutaneous melanoma who have progressed following treatment with an anti-PD-1 therapy.

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth Research Institute
        • Contact:
        • Principal Investigator:
          • Rizwan Khawaja, MD
    • California
      • Bakersfield, California, United States, 93309
        • Recruiting
        • Comprehensive Blood and Cancer Center
        • Contact:
        • Principal Investigator:
          • Ravindranath Patel, MD
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Yung Lyou, MD
        • Contact:
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
        • Sub-Investigator:
          • Omid Hamid, MD
        • Principal Investigator:
          • Navid Hafez, MD
        • Contact:
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
        • Principal Investigator:
          • Katy Tsai, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Ryan Sullivan, MD
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
        • Principal Investigator:
          • Patrick Cobb, MD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine - New York Presbyterian Hospital
        • Principal Investigator:
          • Anna Pavlick, DO
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati Cancer Center
        • Principal Investigator:
          • Trisha Wise-Draper, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC
        • Principal Investigator:
          • Jeffery Russell, MD
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Andrew Poklepovic, MD
        • Contact:
          • Faith McFadden
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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 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

Phase 1 Expansion Cohorts Specific Inclusion Criteria (in addition to above inclusion criteria):

  • 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.

Phase 2 Specific Inclusion Criteria (in addition to above inclusion criteria):

  • 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.

Key Exclusion Criteria:

  • 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)

  • 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.

Note: Neurological symptoms that are considered sequelae to treatment for brain metastases are allowed.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Single Agent
GIM-531 administered orally daily
Drug: GIM-531
GIM-531 administered orally daily
Experimental: Phase 2 Combination Treatment
GIM-531 administered orally daily in combination with anti-PD-1 therapy
Drug: GIM-531
GIM-531 administered orally daily
Drug: Anti-PD-1 monoclonal antibody
Continued treatment with anti-PD-1 therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year
Dose limiting toxicities (DLT) with GIM-531
Time Frame: 21 days
To identify dose limiting toxicities with GIM-531
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
To preliminarily evaluate the Cmax in patients with advanced solid tumors
Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Time to maximum plasma concentration (Tmax)
Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
To preliminarily evaluate Tmax in patients with advanced solid tumors
Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Area under the plasma concentration versus time curve (AUC)
Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
To preliminarily evaluate the AUC in patients with advanced solid tumors
Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Objective response rate (ORR)
Time Frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
To identify objective response rate in patients with advanced solid tumors
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Best overall response (BOR)
Time Frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
To preliminarily evaluate BOR in patients with advanced solid tumors
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Duration of response (DOR)
Time Frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
To preliminarily evaluate DOR in patients with advanced solid tumors
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Disease control rate (DCR)
Time Frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
To preliminarily evaluate DCR in patients with advanced solid tumors
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Progression-free survival (PFS)
Time Frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
To preliminarily evaluate PFS in patients with advanced solid tumors
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Overall survival (OS) rates
Time Frame: From study enrollment until death from any cause (OS rate assessed at 12 months)
To preliminarily evaluate OS in patients with advanced solid tumors, including 12 month OS
From study enrollment until death from any cause (OS rate assessed at 12 months)
Tumor expression of immunological markers
Time Frame: Cycle 1 Days 1, 2 and 8; Cycle 2 Days 1 and 8; Cycle 3 Day 1 (each Cycle is 14 days)
To analyze tumor expression of immunological markers
Cycle 1 Days 1, 2 and 8; Cycle 2 Days 1 and 8; Cycle 3 Day 1 (each Cycle is 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgiamune Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM531-CT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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