Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
Georgiamune Inc
Study ID
NCT06028074
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Malignancies

Eligibility Criteria

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

Interventions

  • GIM122 — DRUG
    GIM-122 administered IV once every 3 weeks or every 2 weeks

Study Details

GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.

Key Dates

Start date
Dec 12, 2023
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
111 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous administration of GIM-122
    GIM-122

Primary Outcome Measure

Dose limiting toxicities [DLT] with GIM-122 [ Time Frame: 18 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025
310-294-0438
Omid Hamid, MD, PhD (PRINCIPAL_INVESTIGATOR)
UCLA Hematology/OncologyLos AngelesCalifornia90095
Thu Ly
[email protected]
310-794-3883
Bartosz Chmielowski, MD, PhD (PRINCIPAL_INVESTIGATOR)
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Gino In, MD (PRINCIPAL_INVESTIGATOR)
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94143
Markee Micu
[email protected]
415-319-3400
Katy Tsai, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsSarasotaFlorida34232
Kandyce Treijo
941-377-9993
Manish Rajni Patel, MD (PRINCIPAL_INVESTIGATOR)
Norton Cancer InstituteLouisvilleKentucky40202
Juanita Dwingelo, MS, PhD, ACRP-CP
[email protected]
502-629-3681
Jaspreet Grewal, MD, PhD (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of NJNew BrunswickNew Jersey08903
Taryn Bollaro
[email protected]
732-853-3229
Sanjay Goel, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Oncology, PLLCNashvilleTennessee37203
Amber Hilyard
[email protected]
Jeffery S Russell, MD, PhD (PRINCIPAL_INVESTIGATOR)
Texas Oncology - Baylor Sammons Cancer CenterDallasTexas75246
Charles Cowey, MD
214-370-1000
Stephanie Cannon
972-490-2939
Thomas Hutson, DO (PRINCIPAL_INVESTIGATOR)
NEXT Oncology DallasIrvingTexas75039
Alexis Praytor
972-893-8800
Shiraj Sen, MD, PhD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23298
Faith McFadden
[email protected]
804-628-0616
Jonathan Berkman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
The Angeles Clinic and Research Institute· Los Angeles, CAUCLA Hematology/Oncology· Los Angeles, CAUSC/Norris Comprehensive Cancer Center· Los Angeles, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAFlorida Cancer Specialists· Sarasota, FLNorton Cancer Institute· Louisville, KY

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