GIM-122 as a Single Agent in Advanced Solid Malignancies

What is the Purpose of this Study?

The purpose of this study is to evaluate an investigational drug called GIM-122 in people who have been diagnosed with an advanced or malignant tumors. These patients have tumors that were eligible to be treated with PD-1/PD-L1 therapy (approved by the U.S. Food and Drug Administration-FDA) and were previously treated with PD-1/PD-L1 immunotherapy. PD-1/PD-L1 is a protein that is on the tumor cells; immunotherapy is a treatment that uses the patient’s own immune system to fight cancer. Researchers will evaluate the safety of GIM-122 and identify a dose of GIM-122 that would be safe to use. The study also aims to learn how the body processes GIM-122. GIM-122 is a humanized monoclonal antibody (laboratory-produced antibody to stimulate the immune cells) that works in two ways. First, it targets a specific protein called PD-1. Cancer cells produce PD-1 to prevent the immune system from attacking it. GIM-122 blocks this protein so that the immune system may be able to help fight cancer. Secondly, GIM-122 activates immune cells in a new fashion to specifically activate these cells to fight cancer. In these ways, GIM-122 works targets the PD-1 pathway in a novel manner.

Eligibility

General
* Written informed consent
* ECOG performance status 0-1.

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 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

Exclusion Criteria:

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
* 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).

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Where can I participate?

CS Cancer at The Angeles Clinic and Research Institute : Crystal Ducharme, Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

GIM122-CT01: 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

Study Details

Disease Type/Condition

Breast, Cervix, Colon, Esophagus, Kidney, Liver, Lung, Melanoma, Other Female Genital, Other Skin

Principal Investigator

Hamid, Omid

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Justin Moyers, Kristopher Wentzel, Navid Hafez, Vi K. Chiu

Age Group

Adult

Phase

I/II

IRB Number

STUDY00002832

ClinicalTrials.gov ID

NCT06028074

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org