A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title: An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2a Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Therapeutic Activity of GI-102 in Patients With Advanced or Metastatic Solid Tumors

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent over a range of advanced and/or metastatic solid tumors.

Clinical Trial Description

This is a phase 1/2a, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, and anti-tumor effect of GI-102 as a single agent over a range of advanced and/or metastatic solid tumors. This study is adaptive in nature. While GI-102 is being investigated as a single agent in this trial, GI-102 has the potential of being combined with other agents. Based on the data from ongoing nonclinical studies and the dose escalation phase, additional combination therapies [GI-102 + drug(s) X] may be proposed and added to this study protocol via an amendment.

This study will comprise two phases.

• GI-102 monotherapy dose escalation phase

• GI-102 monotherapy dose expansion phase

GI-102 is a novel bi-specific Fc fusion protein containing the CD80 ectodomain as an N-terminal moiety and an interleukin (IL)-2 variant as a C-terminal moiety configurated via a human immunoglobulin G4 (IgG4) Fc. GI-102 has unique characteristics by having bispecificity to CD80 and IL2Rβγ. The CD80 portion is responsible for targeting tumor/immune cells while blocking CTLA-4 expressed on the Treg cells. The IL-2v of GI-102 is designed to abolish IL-2Rα affinity and therefore minimize the effect on Treg while it has very outstanding effect on NK and CD8 T cell proliferation and activity through IL-2Rbr affinity. ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Metastatic Solid Tumor
• Neoplasms

• NCT number: NCT05824975
• Study type: Interventional
• Source: GI Innovation, Inc.
• Contact: Jay Kim
• Phone: +82-2-404-2003
• Email: Clinical-102@gi-innovation.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 30, 2023
• Completion date: June 30, 2025