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

Launched by GEORGIAMUNE INC · Aug 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called GIM-122 for adults with advanced solid tumors, which are types of cancer that have spread and are difficult to treat. The main goal of the trial is to find out how safe GIM-122 is and how well it works when given through an IV. Researchers want to learn about any side effects and how the drug moves through the body.

To participate in the trial, individuals must be adults aged 18 or older who have already tried certain approved cancer treatments and found that they are no longer working. They need to have a confirmed diagnosis of advanced cancer that is either locally advanced or has spread to other parts of the body. Participants will undergo tests to ensure their heart, kidney, and liver functions are acceptable, and they must agree to use effective birth control during and after treatment. If eligible, participants can expect to receive the treatment and will be closely monitored for any responses or changes in their condition throughout the study. It’s important to note that individuals currently undergoing other cancer therapies or those with certain health conditions may not qualify for this trial.

Gender

ALL

Eligibility criteria

• 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
• • 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).