RecruitingPhase 1Phase 2NCT06028074

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

A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation With Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects With Advanced Solid Malignancies

Sponsor

Georgiamune Inc

Enrollment

111 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Malignancies

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GIM122 for people with advanced solid malignancies. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGIM122

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

Locations(11)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Texas Oncology - Baylor Sammons Cancer Center

Dallas, Texas, United States

NEXT Oncology Dallas

Irving, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06028074

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