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NCT06028074 | RECRUITING | Advanced Solid Malignancies

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

Georgiamune Inc

Brief 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.

Condition or disease

Advanced Solid Malignancies

Intervention/treatment

GIM122

Phase

PHASE1

PHASE2

Detailed Description:

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 111 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-12-12
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

Location Details

NCT06028074

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

The Angeles Clinic and Research Institute

Los Angeles, California, United States, 90025

RECRUITING

United States, California

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

RECRUITING

United States, California

UCLA Hematology/Oncology

Los Angeles, California, United States, 90095

RECRUITING

United States, California

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States, 94143

RECRUITING

United States, Florida

Florida Cancer Specialists

Sarasota, florida, United States, 34232

RECRUITING

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, United States, 08903

RECRUITING

United States, Tennessee

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Texas Oncology - Baylor Sammons Cancer Center

dallas, Texas, United States, 75246

RECRUITING

United States, Texas

NEXT Oncology Dallas

Irving, Texas, United States, 75039

RECRUITING

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298