GI-108 monotherapy for people 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
We are testing GI-108 by itself to see if it is safe and can shrink tumors in people with advanced or metastatic solid tumors, including lung, head and neck, and pancreatic cancers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GI Innovation, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Seoul and 2 other locations) |
| Trial ID | NCT07172802 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter phase 1/2 trial gives GI-108 as a single agent to adults with advanced or metastatic solid tumors. The study uses a dose-escalation phase to establish a maximum tolerated or recommended phase 2 dose, followed by dose-expansion cohorts that may be enriched for specific tumor types or characteristics. Primary assessments include safety, tolerability, pharmacokinetics and pharmacodynamics, with anti-tumor activity measured by RECIST v1.1. There is no control arm and cohort expansion decisions are made by a Safety Monitoring Committee based on emerging safety, PK, PD and efficacy data.
Who should consider this trial
Good fit: Adults (≥18 years) with measurable advanced or metastatic solid tumors, ECOG performance status 0–1, adequate organ and marrow function, and prior therapy–related toxicities resolved to Grade ≤1 are the intended candidates.
Not a fit: Patients with active CNS metastases or carcinomatous meningitis, active hepatitis B or C, active tuberculosis, uncontrolled infections, or inadequate organ function are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, GI-108 could offer a new immune-based treatment that boosts anti-tumor responses and may shrink tumors in these hard-to-treat cancers.
How similar studies have performed: Related approaches targeting CD73 or using engineered IL-2 variants have shown promising early-phase signals but are not yet proven in later-stage trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul and 2 other locations
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Seunghwan Shin, M.D.
- Email: clinical-108@gi-innovation.com
- Phone: +82-2-404-2003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.