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

Georgiamune

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Advanced Solid Malignancies

Treatments

Drug: GIM122

Study type

Interventional

Funder types

Industry

Identifiers

NCT06028074

GIM122-CT01

Details and patient eligibility

About

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.

Full 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).

Enrollment

111 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).