Recruiting
Phase 1
Phase 2

GIM-122

Sponsor:

Georgiamune Inc

Code:

NCT06028074

Conditions

Advanced Solid Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GIM122

Study Details

Brief summary:

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.

Conditions

Advanced Solid Malignancies

Study ID

NCT06028074

Start date

Dec 12, 2023

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

General

  • Written informed consent
  • ECOG performance status 0-1.
  • Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions
  • Recommended Double methods of contraception 90-days post treatment Cancer Specific
  • Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor
  • Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
  • Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
  • No other lines of therapy that are available

Exclusion Criteria:

General

  • Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
  • Women who are pregnant or breastfeeding
  • History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
  • Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
  • Current second malignancy at other sites
  • Leptomeningeal disease
  • Spinal cord compression
  • Symptomatic or new or enlarging central nervous system (CNS) metastases

Treatment-specific Exclusion Criteria

  • Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
  • Has undergone a major surgery < 1 month prior to administration of GIM-122
  • Has received radiation therapy within 2 weeks prior to administration of GIM-122
  • Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
  • Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
  • Prior treatment with other immune modulating agents within < 4 weeks prior to the first dose of GIM-122.
  • Has a diagnosis of immunodeficiency, either primary or acquired
  • Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
  • Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
  • Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
  • Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date > 30 days prior to administration of GIM-122).

Study Design

Enrollment

111 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intravenous administration of GIM-122

GIM-122

Interventions

GIM122

GIM-122 administered IV once every 3 weeks or every 2 weeks

Primary outcome measure

  • Dose limiting toxicities [DLT] with GIM-122 [ Time Frame: 18 months ]
  • Maximum tolerated dose [MTD] of GIM-122 [ Time Frame: 18 months ]
  • Recommended Phase 2 Dose [RP2D] of GIM-122 [ Time Frame: 18 Months ]
  • Overall response rate (ORR) -Part B of the study [ Time Frame: 36 months ]
  • Anti-tumor activity of GIM-122 [ Time Frame: 36 months ]
  • Incidence and severity of AE / SAEs and tolerability [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

LumaBridge CRO

210-563-8441contact@lumabridge.com

Locations

The Angeles Clinic and Research Institute

Recruiting

Los Angeles, California, United States, 90025

Contacts

310-294-0438

Principal Investigator:

Omid Hamid, MD, PhD

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Thomas Won

thomas.won@med.usc.edu

Principal Investigator:

Gino In, MD

UCLA Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90095

Contacts

Thu Ly

310-794-3883tply@mednet.ucla.edu

Principal Investigator:

Bartosz Chmielowski, MD, PhD

UCSF Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Markee Micu

415-319-3400markee.micu@ucsf.edu

Principal Investigator:

Katy Tsai, MD

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Kandyce Treijo

941-377-9993

Principal Investigator:

Manish Rajni Patel, MD

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Juanita Dwingelo, MS, PhD, ACRP-CP

502-629-3681juanita.vondwingelo@nortonhealthcare.org

Principal Investigator:

Jaspreet Grewal, MD, PhD

Rutgers Cancer Institute of NJ

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Taryn Bollaro

732-853-3229tb509@cinj.rutgers.edu

Principal Investigator:

Sanjay Goel, MD

Tennessee Oncology, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Amber Hilyard

ahilyard@tnonc.com

Principal Investigator:

Jeffery S Russell, MD, PhD

Texas Oncology - Baylor Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Charles Cowey, MD

214-370-1000

Stephanie Cannon

972-490-2939

Principal Investigator:

Thomas Hutson, DO

NEXT Oncology Dallas

Recruiting

Irving, Texas, United States, 75039

Contacts

Alexis Praytor

972-893-8800

Principal Investigator:

Shiraj Sen, MD, PhD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Faith McFadden

804-628-0616mcfaddenfr@vcu.edu

Principal Investigator:

Jonathan Berkman, MD

More Information

Sponsor

Georgiamune Inc

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • solid tumor
  • advanced malignancies
  • GIM-122

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Georgiamune Inc on 2026-08-17.