RecruitingPhase 1Phase 2NCT07172802

A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as a Single Agent in Patients With Advanced or Metastatic Solid Tumors


Sponsor

GI Innovation, Inc.

Enrollment

76 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a new immunotherapy drug called GI-108 — which both targets a molecule that suppresses the immune system (CD73) and activates immune cells (IL-2) — in people with advanced or metastatic solid tumors that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older with an advanced or metastatic solid tumor - You have measurable disease and are in reasonable physical condition (ECOG 0–1) - Side effects from any prior cancer treatment have mostly resolved - If you have HIV, it must be well-controlled on antiretroviral therapy **You may NOT be eligible if...** - You have active brain metastases or another active cancer - You have active hepatitis B, hepatitis C, or active tuberculosis - You have chronic liver disease or cirrhosis (unless from liver metastases) - You have an active autoimmune disease requiring systemic treatment - You have had a serious infection within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGI-108

Dose level will be escalated from 0.1mg/kg to 0.6 mg/kg and Recommended phase 2 dose (or RP2D) of GI-108 will be administered via IV infusion Q3W upto 2 years (approximately 35 years)


Locations(3)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

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NCT07172802


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