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

NCT06028074 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GIM122-CT01
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 11

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.

Conditions

Advanced Solid Malignancies

Keywords

solid tumor; advanced malignancies; GIM-122

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Area under the plasma concentration versus time curve (AUC)

  36 months

• Peak Plasma Concentration (Cmax)

  36 months

• Time of peak plasma concentration (Tmax)

  36 months

• Overall Response Rate (ORR) - Part A of the study

  36 months

• Duration of response (DOR)

  36 months

Study Arms (1)

Intravenous administration of GIM-122

EXPERIMENTAL

GIM-122

Drug: GIM122

Interventions

GIM122 DRUG

GIM-122 administered IV once every 3 weeks or every 2 weeks

Also known as: GIM-122

Intravenous administration of GIM-122

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Georgiamune Inc: lead

Study Sites (11)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

RECRUITING

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

UCLA Hematology/Oncology

Los Angeles, California, 90095, United States

RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

RECRUITING

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

RECRUITING

Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, 08903, United States

RECRUITING

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

NEXT Oncology Dallas

Irving, Texas, 75039, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• Omid Hamid, MD

  The Angeles Clinic and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LumaBridge CRO

CONTACT

210-563-8441; contact@lumabridge.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Dose Escalation and Enrichment, Part B: Dose Expansion in specified tumor types

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)