Actively Recruiting
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
Led by GI Innovation, Inc. · Updated on 2025-09-15
76
Participants Needed
3
Research Sites
123 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older (or 19 years per local guidelines) at screening
- Adequate organ and bone marrow function as defined in the protocol
- Measurable disease according to RECIST version 1.1
- ECOG performance status of 0 or 1
- Side effects from prior chemotherapy, radiotherapy, immunotherapy, or surgery resolved to Grade 1 or less, except for alopecia and Grade 2 peripheral neuropathy
- HIV-positive patients on anti-retroviral therapy with well-controlled infection as defined in the protocol
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis
- Active second malignancy
- Active or history of Hepatitis B or active Hepatitis C infection
- Active or history of active tuberculosis
- Active or uncontrolled infections or severe infection within 4 weeks before treatment
- History of chronic liver disease or cirrhosis, except for liver metastasis
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Prior immunotherapies related to the mode of action of GI-102
- Diagnosed immunodeficiency or currently receiving chronic systemic steroids or other immunosuppressive medication within 2 weeks before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
2
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
3
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
S
Seunghwan Shin, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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