Evaluating GI-102 for advanced solid tumors with or without other cancer drugs
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-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)
This study is testing a new cancer treatment called GI-102, both on its own and with other cancer drugs, to see how safe it is and how well it works for people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GI Innovation, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, pembrolizumab, trastuzumab |
| Locations | 11 sites (Scottsdale, Arizona and 10 other locations) |
| Trial ID | NCT05824975 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and therapeutic activity of GI-102, a novel bi-specific immunotherapy, both as a standalone treatment and in combination with conventional anti-cancer drugs like pembrolizumab and trastuzumab deruxtecan. It is a phase 1/2, open-label, dose-escalation and expansion study that includes multiple parts focusing on different treatment combinations and dosing strategies. The study aims to assess the drug's pharmacokinetics, tolerability, and anti-tumor effects across various advanced and metastatic solid tumors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors who have measurable disease and meet specific health criteria.
Not a fit: Patients with active CNS metastases, second malignancies, or uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors, potentially improving outcomes and survival rates.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing immunotherapy for advanced cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) 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 steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1. * Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment. * Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy. * Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1. * Known hypersensitivity to any of the components of the drug products and/or excipients of GI-102. Other protocol defined inclusion exclusion criteria may apply
Where this trial is running
Scottsdale, Arizona and 10 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Minnesota — Rochester, Minnesota, United States (Recruiting)
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
- St. Vincent's Hospital — Suwon, suwon, South Korea (Recruiting)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)
- 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: Jay Kim
- Email: Clinical-102@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.