Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
NCT06028074 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 111
Last updated 2025-07-11
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
Interventions
- DRUG
-
GIM122
GIM-122 administered IV once every 3 weeks or every 2 weeks
Sponsors & Collaborators
-
Georgiamune Inc
lead INDUSTRY
Principal Investigators
-
Omid Hamid, MD · The Angeles Clinic and Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-12
- Primary Completion
- 2026-09-30
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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