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Clinical Trial 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.


Clinical Trial Description

This is a Phase 1/2, open label, first-in-human (FIH), multicenter, dose escalation study with enrichments and dose expansion cohorts at RP2D, designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of GIM-122 administered as a single agent in adults with advanced solid malignancies. This study will be conducted in 2 parts: Phase 1 or Part A (dose escalation and enrichment) and Phase 2 or Part B (dose optimization and cohort expansion). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06028074
Study type Interventional
Source Georgiamune Inc
Contact LumaBridge CRO
Phone 210-563-8441
Email contact@lumabridge.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 12, 2023
Completion date December 2026

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