Melanoma Stage IVPhase 1/2NCT06425926
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
A Phase 1/2 study testing GIM-531 and Anti-PD-1 monoclonal antibody in people with Melanoma Stage IV and Solid Tumor, run by Georgiamune Inc at 11 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Stage IV, Solid Tumor
- What is being tested?
- GIM-531 and Anti-PD-1 monoclonal antibody
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 11 sitesUnited States
- Study dates
- 9 May 2024to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Nicole Ward, 661-862-8548, nward@cbccusa.com
Ravindranath Patel, MD
- Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, 59102
Matt Adler, 406-238-6894, matt.adler@imail.org
Patrick Cobb, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ryan Sullivan, MD, 617-724-4000, RSULLIVAN7@mgh.harvard.edu
Ryan Sullivan, MD
- Recruiting
University of Cincinnati Cancer Center
Cincinnati, Ohio, 45267
Trisha Wise-Draper, MD
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
Kendall Karp, 714-446-5177, kendall.karp@providence.org
Yung Lyou, MD
- Recruiting
The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025
Navid Hafez, MD, nhafez@theangelesclinic.org
Saba Mukarram, 310-231-2181, smukarram@theangelesclinic.org
- Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Jeffery Russell, MD
- Recruiting
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, 10065
Anna Pavlick, DO
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23219
Faith McFadden
804-628-7978, masseysiit@vcu.edu
- Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Sonia Contreras Martinez, 415-514-6427, Sonia.ContrerasMartinez@ucsf.edu
Katy Tsai, MD
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Andrew Islas, 480-583-7474, anislas@honorhealth.com
Rizwan Khawaja, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Melanoma Stage IV, Solid Tumor
- Being tested
- GIM-531, Anti-PD-1 monoclonal antibody
- Keywords
- PD-1 resistance, PD-1 resistant/refractory, AKT3
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIM-531Drug
GIM-531 administered orally daily
Anti-PD-1 monoclonal antibodyDrug
Continued treatment with anti-PD-1 therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Single Agent | Experimental | GIM-531 administered orally daily Receives: Drug: GIM-531 |
| Phase 2 Combination Treatment | Experimental | GIM-531 administered orally daily in combination with anti-PD-1 therapy Receives: Drug: GIM-531; Drug: Anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability
To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading
Measured: Through study completion, an average of 1 year
Dose limiting toxicities (DLT) with GIM-531
To identify dose limiting toxicities with GIM-531
Measured: 21 days
Secondary outcomes (10)
Maximum plasma concentration (Cmax)
To preliminarily evaluate the Cmax in patients with advanced solid tumors
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Time to maximum plasma concentration (Tmax)
To preliminarily evaluate Tmax in patients with advanced solid tumors
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Area under the plasma concentration versus time curve (AUC)
To preliminarily evaluate the AUC in patients with advanced solid tumors
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Objective response rate (ORR)
To identify objective response rate in patients with advanced solid tumors
Measured: 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)
To preliminarily evaluate BOR in patients with advanced solid tumors
Measured: 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)
To preliminarily evaluate DOR in patients with advanced solid tumors
Measured: 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)
To preliminarily evaluate DCR in patients with advanced solid tumors
Measured: 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)
To preliminarily evaluate PFS in patients with advanced solid tumors
Measured: 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
To preliminarily evaluate OS in patients with advanced solid tumors, including 12 month OS
Measured: From study enrollment until death from any cause (OS rate assessed at 12 months)
Tumor expression of immunological markers
To analyze tumor expression of immunological markers
Measured: Cycle 1 Days 1, 2 and 8; Cycle 2 Days 1 and 8; Cycle 3 Day 1 (each Cycle is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start9 May 2024
- Primary completionDec 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgiamune Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425926
- Sponsor's protocol ID
- GIM531-CT01
- Status last verified
- Aug 2026
- First submitted
- 16 May 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06425926
- Acronym / sponsor ID
- GIM531-CT01
- Conditions
- Melanoma Stage IV, Solid Tumor
- Keywords
- PD-1 resistance, PD-1 resistant/refractory, AKT3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Georgiamune IncIndustry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Single Agent | Experimental | Drug: GIM-531GIM-531 administered orally daily |
| Phase 2 Combination Treatment | Experimental | Drug: GIM-531, Drug: Anti-PD-1 monoclonal antibodyGIM-531 administered orally daily in combination with anti-PD-1 therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIM-531GIM-531 administered orally daily | Drug | Phase 1 Single Agent, Phase 2 Combination Treatment |
| Anti-PD-1 monoclonal antibodyContinued treatment with anti-PD-1 therapy | Drug | Phase 2 Combination Treatment |
Primary outcome
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
10 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 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
Area under the plasma concentration versus time curve (AUC)
Time frame: 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)
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)
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)
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)
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)
Overall survival (OS) rates
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GIM-531 and Anti-PD-1 monoclonal antibody in people with Melanoma Stage IV and Solid Tumor, run by Georgiamune Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayadev Sureddi, CBCC CRO ((661) 616-6453, jayadev.sureddi@cbcc.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.