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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Georgiamune Inc
Study ID
NCT06425926
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Melanoma Stage IV
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GIM-531 — DRUG
    GIM-531 administered orally daily
  • Anti-PD-1 monoclonal antibody — DRUG
    Continued treatment with anti-PD-1 therapy

Study Details

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).

Key Dates

Start date
May 9, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
117 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Single Agent
    GIM-531 administered orally daily
  • Experimental: Phase 2 Combination Treatment
    GIM-531 administered orally daily in combination with anti-PD-1 therapy

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 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Andrew Islas
[email protected]
480-583-7474
Rizwan Khawaja, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309
Nicole Ward
[email protected]
661-862-8548
Ravindranath Patel, MD (PRINCIPAL_INVESTIGATOR)
Providence Medical FoundationFullertonCalifornia92835
Kendall Karp
[email protected]
714-446-5177
Yung Lyou, MD (PRINCIPAL_INVESTIGATOR)
The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos AngelesCalifornia90025
Navid Hafez, MD
[email protected]
Saba Mukarram
[email protected]
310-231-2181
Navid Hafez, MD (PRINCIPAL_INVESTIGATOR)
Omid Hamid, MD (SUB_INVESTIGATOR)
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94143
Sonia Contreras Martinez
[email protected]
415-514-6427
Katy Tsai, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Ryan Sullivan, MD
[email protected]
617-724-4000
Ryan Sullivan, MD (PRINCIPAL_INVESTIGATOR)
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of MontanaBillingsMontana59102
Matt Adler
[email protected]
406-238-6894
Patrick Cobb, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medicine - New York Presbyterian HospitalNew YorkNew York10065
Anna Pavlick, DO (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer CenterCincinnatiOhio45267
Trisha Wise-Draper, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Oncology, PLLCNashvilleTennessee37203
Jeffery Russell, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23219
Faith McFadden
[email protected]
804-628-7978
Andrew Poklepovic, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute· Scottsdale, AZComprehensive Blood and Cancer Center· Bakersfield, CAProvidence Medical Foundation· Fullerton, CAThe Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate· Los Angeles, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAMassachusetts General Hospital· Boston, MA

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