Georgiamune Inc
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.
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).
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 Evalua…
GIM-122 administered IV once every 3 weeks or every 2 weeks