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

Advanced Solid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028074
• Other study ID #: GIM122-CT01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 12, 2023
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Georgiamune Inc
• Contact: LumaBridge CRO
• Phone: 210-563-8441
• Email: contact[@]lumabridge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Intervention

Drug:
• GIM122
GIM-122 administered IV once every 3 weeks

Locations

Country	Name	City	State
United States	Texas Oncology - Baylor Sammons Cancer Center	Dallas	Texas
United States	NEXT Oncology Dallas	Irving	Texas
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	Rutgers Cancer Institute of NJ	New Brunswick	New Jersey
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Georgiamune Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicities [DLT] with GIM-122	To identify dose limiting toxicities [DLT] with GIM-122	18 months
Primary	Maximum tolerated dose [MTD] of GIM-122	To identify maximum tolerated dose [MTD] of GIM-122	18 months
Primary	Recommended Phase 2 Dose [RP2D] of GIM-122	To identify Recommended Phase 2 Dose [RP2D] of GIM-122	18 Months
Primary	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
Primary	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
Primary	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	Area under the plasma concentration versus time curve (AUC)	To preliminarily evaluate the AUC in patients with advanced malignant tumors	36 months
Secondary	Peak Plasma Concentration (Cmax)	To preliminarily evaluate Cmax in patients with advanced malignant tumors	36 months
Secondary	Time of peak plasma concentration (Tmax)	To preliminarily evaluate Tmax in patients with advanced malignant tumors	36 months
Secondary	Overall Response Rate (ORR) - Part A of the study	To preliminarily evaluate ORR in patients with advanced malignant tumors	36 months
Secondary	Duration of response (DOR)	To preliminarily evaluate DOR in patients with advanced malignant tumors	36 months
Secondary	Disease control rate (DCR)	To preliminarily evaluate DCR in patients with advanced malignant tumors	36 months
Secondary	Best overall response (BOR)	To preliminarily evaluate BOR in patients with advanced malignant tumors	36 months
Secondary	Progression-free survival (PFS)	To preliminarily evaluate PFS in patients with advanced malignant tumors	36 months
Secondary	Overall survival (OS) rates at 12 months	To preliminarily evaluate OS in patients with advanced malignant tumors at 12 Months	36 months
Secondary	Tumor expression of immunological markers	To analyze tumor expression of immunological markers	36 months