Actively Recruiting
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
Led by GI Innovation, Inc. · Updated on 2025-09-15
76
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes (pharmacokinetics), and the therapeutic effects of GI-108, an anti-CD73-IgG4 Fc-IL-2v bispecific fusion protein, in adults with advanced or metastatic solid tumors. This open-label, multicenter phase 1/2 study includes patients with various advanced cancers such as non-small cell lung cancer, head and neck cancer, pancreatic cancer, and renal cell carcinoma. The study aims to identify the best dose and gather early evidence of anti-tumor activity without a control group. The study has two main parts: a dose escalation phase and a dose expansion phase. In dose escalation, up to 36 patients receive increasing doses of GI-108 given by intravenous infusion every three weeks to find the maximum tolerated dose or recommended dose for phase 2. Dose expansion involves giving the recommended dose to more patients to confirm safety and anti-tumor effects. Treatment may continue for up to approximately 2 years. No placebo or control arm is included. Participants will undergo safety and efficacy assessments including monitoring for dose-limiting toxicities, immune-related side effects, and tumor response using RECIST version 1.1 criteria. Blood samples will be taken to study drug levels and how GI-108 behaves in the body. Researchers will follow patients for up to about 24 months to evaluate tumor control, response duration, progression-free survival, and overall survival. The study will also track pharmacokinetic measures such as peak concentration and clearance of GI-108.
CONDITIONS
Brief 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...
- Male and female participants aged 18 years or older at screening
- Adequate organ and marrow function as defined in the protocol
- Measurable disease according to RECIST version 1.1
- ECOG performance status of 0 or 1
- Any side effects from prior cancer treatments have resolved to mild or less, except for alopecia and Grade 2 peripheral neuropathy
- HIV-positive patients must be on anti-retroviral therapy with well-controlled infection
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis
- Presence of an active second malignancy
- Active or known history of Hepatitis B or active Hepatitis C infection
- Active tuberculosis or history of active tuberculosis
- Active or uncontrolled infections or severe infection within 4 weeks before treatment
- History of chronic liver disease or liver cirrhosis, except liver metastasis
- Active autoimmune disease requiring systemic treatment within past 2 years
- Previous immunotherapies related to GI-102's mode of action
- Diagnosis of immunodeficiency or current use of chronic systemic steroids or immunosuppressive therapy within 2 weeks prior to study treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive GI-108 via intravenous infusion every 3 weeks as a single agent to treat advanced or metastatic solid tumors. Dose levels will be escalated to establish the recommended phase 2 dose, followed by treatment at this dose for up to 2 years.
Infusions every 3 weeks
Duration - Up to approximately 24 months
Participants are monitored for safety, tolerability, and anti-tumor activity after treatment completion, including assessments up to approximately 24 months from treatment start.
Periodic visits for assessments during and after treatment
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.
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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