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

G

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

111 participants in 1 patient group

Intravenous administration of GIM-122
Experimental group
Description:
GIM-122
Treatment:
Drug: GIM122

Trial contacts and locations

7

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Central trial contact

LumaBridge CRO

Data sourced from clinicaltrials.gov

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