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Clinical Trials in South Korea / NCT07172802
Recruiting Phase 1/2

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

NCT07172802 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 1/2
Started
2025-04-22
Last updated
2026-09-17

Condition(s) studied

Advanced Solid TumorMetastatic Solid TumorNon-small Cell Lung Cancer (NSCLC)Head and Neck (HNSCC)Pancreatic CancerRenal Cell Carcinoma (RCC)

Investigational drug(s) / intervention(s)

GI-108

GI-108: Dose level will be escalated from 0.1mg/kg to 1.5 mg/kg and Recommended phase 2 dose (or RP2D) of GI-108 will be administered via IV infusion Q3W upto 2 years (approximately 35 cycles)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) at the time of screening. * Has adequate organ and marrow function as defined in protocol. * Measurable disease as per RECIST v1.1. * ECOG performance status 0-1. * Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy,other prior systemic anti-cancer therapy, or surgery must have resolved to Grade≤1, except alopecia and Grade 2 peripheral neuropathy. * HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease as defined in protocol. Key Exclusion Criteria: * Has known active CNS metastases and/or carcinomatous meningitis. An active second malignancy. * Has active or a known history of Hepatitis B or known active Hepatitis C virus infection. * Has active tuberculosis or has a known history of active tuberculosis. Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration. * History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Previous immunotherapies related to mode of action of GI-102. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroidtherapy or any other form of immunosuppressive medications within 2 weeksprior to Cycle 1 Day 1.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Yonsei University Health System, Severance Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07172802 on ClinicalTrials.gov ↗ ← All trials in South Korea