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MD",{"type":210,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100518248",false,"NCT06028074","Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies","A First-in-Human, Open-Label, Phase 1\u002F2 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","Inclusion Criteria:\n\nGeneral\n\n* Written informed consent\n* ECOG performance status 0-1.\n* Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions\n* Recommended Double methods of contraception 90-days post treatment Cancer Specific\n* Histologically or cytologically confirmed locally advanced\u002Funresectable or metastatic solid tumor\n* Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed\u002Frelapsed, are refractory, or intolerant\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1\n* Had prior therapy with PD-1\u002FPD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation\n* No other lines of therapy that are available\n\nExclusion Criteria:\n\nGeneral\n\n* 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\n* Women who are pregnant or breastfeeding\n* History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing\n* 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\n* Current second malignancy at other sites\n* Leptomeningeal disease\n* Spinal cord compression\n* Symptomatic or new or enlarging central nervous system (CNS) metastases\n\nTreatment-specific Exclusion Criteria\n\n* Ongoing toxicity \\> Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0\n* Has undergone a major surgery \\\u003C 1 month prior to administration of GIM-122\n* Has received radiation therapy within 2 weeks prior to administration of GIM-122\n* Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time\n* 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\n* Prior treatment with other immune modulating agents within \\\u003C 4 weeks prior to the first dose of GIM-122.\n* Has a diagnosis of immunodeficiency, either primary or acquired\n* Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122\n* Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids.\n* 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.\n* 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).","ALL","18 Years",{"count":220,"type":221},111,"ESTIMATED","INTERVENTIONAL",[224,225],"PHASE1","PHASE2","GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 \u002F 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.",[228],"Advanced Solid Malignancies",[230,231,11],"solid tumor","advanced malignancies","2025-07-08",{"date":234,"type":235},"2025-07-11","ACTUAL",{"date":237,"type":235},"2023-12-12",{"date":239,"type":221},"2026-12",{"name":5,"class":6},11]