RECRUITING

Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

Conditions

Advanced Solid Malignancies solid tumor advanced malignancies GIM-122

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-12-12

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06028074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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 * 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).

Inclusion Criteria

Exclusion Criteria

* 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

* 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
* 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).

Contacts and Locations

Study Contact

LumaBridge CRO

CONTACT

210-563-8441

contact@lumabridge.com

Principal Investigator

Omid Hamid, MD

PRINCIPAL_INVESTIGATOR

The Angeles Clinic and Research Institute

Study Locations (Sites)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Florida Cancer Specialists

Sarasota, Florida, 34232

United States

Norton Cancer Institute

Louisville, Kentucky, 40202

United States

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, 08903

United States

Texas Oncology - Baylor Sammons Cancer Center

Dallas, Texas, 75246

United States

NEXT Oncology Dallas

Irving, Texas, 75039

United States

Collaborators and Investigators

Sponsor: Georgiamune Inc

Omid Hamid, MD, PRINCIPAL_INVESTIGATOR, The Angeles Clinic and Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-12-12

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

solid tumor
advanced malignancies
GIM-122

Additional Relevant MeSH Terms

Advanced Solid Malignancies