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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Malignancies
• Intervention / Treatment: Drug: GIM122

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
• Enrollment (Estimated): 111
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: LumaBridge CRO; Phone Number: 210-563-8441; Email: contact@lumabridge.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • Recruiting
      • The Angeles Clinic and Research Institute
      • Contact: Phone Number: 310-294-0438
      • Principal Investigator: Omid Hamid, MD, PhD
  • Florida
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • Florida Cancer Specialists
      • Contact: Kandyce Treijo; Phone Number: 941-377-9993
      • Principal Investigator: Manish Rajni Patel, MD
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Texas Oncology - Baylor Sammons Cancer Center
      • Principal Investigator: Thomas Hutson, DO
      • Contact: Thomas Hutson, DO; Phone Number: 214-370-1000
      • Contact: Stephanie Cannon; Phone Number: 972-490-2939
    • Irving, Texas, United States, 75039
      • Recruiting
      • NEXT Oncology Dallas
      • Contact: Alexis Praytor; Phone Number: 972-893-8800
      • Principal Investigator: Shiraj Sen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous administration of GIM-122; GIM-122	Drug: GIM122; GIM-122 administered IV once every 3 weeks; Other Names: GIM-122

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limiting toxicities [DLT] with GIM-122	To identify dose limiting toxicities [DLT] with GIM-122	18 months
Maximum tolerated dose [MTD] of GIM-122	To identify maximum tolerated dose [MTD] of GIM-122	18 months
Recommended Phase 2 Dose [RP2D] of GIM-122	To identify Recommended Phase 2 Dose [RP2D] of GIM-122	18 Months
Overall response rate (ORR) -Part B of the study	To identify overall response rate (ORR) in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy	36 months
Anti-tumor activity of GIM-122	To assess anti-tumor activity of GIM-122 as a single agent in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy	36 months
Incidence and severity of AE / SAEs and tolerability	To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	To preliminarily evaluate the AUC in patients with advanced malignant tumors	36 months
Peak Plasma Concentration (Cmax)	To preliminarily evaluate Cmax in patients with advanced malignant tumors	36 months
Time of peak plasma concentration (Tmax)	To preliminarily evaluate Tmax in patients with advanced malignant tumors	36 months
Overall Response Rate (ORR) - Part A of the study	To preliminarily evaluate ORR in patients with advanced malignant tumors	36 months
Duration of response (DOR)	To preliminarily evaluate DOR in patients with advanced malignant tumors	36 months
Best overall response (BOR)	To preliminarily evaluate BOR in patients with advanced malignant tumors	36 months
Progression-free survival (PFS)	To preliminarily evaluate PFS in patients with advanced malignant tumors	36 months
Overall survival (OS) rates at 12 months	To preliminarily evaluate OS in patients with advanced malignant tumors at 12 Months	36 months
Tumor expression of immunological markers	To analyze tumor expression of immunological markers	36 months
Disease control rate (DCR)	To preliminarily evaluate DCR in patients with advanced malignant tumors	36 months

Collaborators and Investigators

• Sponsor: Georgiamune Inc
• Investigators: Principal Investigator: Omid Hamid, MD, The Angeles Clinic and Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: solid tumor; advanced malignancies; GIM-122
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GIM122-CT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No