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
Apply to this trial

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

First listed
May 23, 2024
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

Related Studies