NCT06028074

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Georgiamune Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	GIM122	GIM-122 administered IV once every 3 weeks or every 2 weeks

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-09-07
• Last updated: 2025-07-11

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study