Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
a study on Solid Malignancies Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA UCSF
- Dates
- study startedcompletion around
- Principal Investigator
- by Bartosz Chmielowski, MD, PhD (ucla)

Description
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.
Official Title
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
Details
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).
Keywords
Advanced Solid Malignancies, solid tumor, advanced malignancies, GIM-122, Neoplasms, GIM122, Intravenous administration of GIM-122
Eligibility
You can join if…
Open to people ages 18 years and up
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 Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation
- No other lines of therapy that are available
You CAN'T join if...
General
- Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy
- Women who are pregnant or breastfeeding
- History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing
- Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific
- Current second malignancy at other sites
- Leptomeningeal disease
- Spinal cord compression
- Symptomatic or new or enlarging central nervous system (CNS) metastases
Treatment-specific Exclusion Criteria
- Ongoing toxicity > Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
- Has undergone a major surgery < 1 month prior to administration of GIM-122
- Has received radiation therapy within 2 weeks prior to administration of GIM-122
- Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time
- Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122
- Prior treatment with other immune modulating agents within < 4 weeks prior to the first dose of GIM-122.
- Has a diagnosis of immunodeficiency, either primary or acquired
- Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122
- Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.
- Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent.
- Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date > 30 days prior to administration of GIM-122).
Locations
- UCLA Hematology/Oncology
accepting new patients
Los Angeles California 90095 United States - UCSF Helen Diller Family Comprehensive Cancer Center
accepting new patients
San Francisco California 94143 United States - The Angeles Clinic and Research Institute
accepting new patients
Los Angeles California 90025 United States - USC/Norris Comprehensive Cancer Center
accepting new patients
Los Angeles California 90033 United States
Lead Scientist at University of California Health
- Bartosz Chmielowski, MD, PhD (ucla)
HS Clinical Professor, Medicine. Authored (or co-authored) 131 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Georgiamune Inc
- ID
- NCT06028074
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 111 study participants
- Last Updated