A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08) (NCT05824975)
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)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic in Arizona — Scottsdale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- Mayo Clinic in Arizona — Scottsdale, Arizona
- Mayo Clinic in Florida — Jacksonville, Florida
- Mayo Clinic in Minnesota — Rochester, Minnesota
- Memorial Sloan-Kettering Cancer Center — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- Seoul National University Hospital — Seoul, Seoul
- St. Vincent's Hospital — Suwon, suwon
- Yonsei University Health System, Severance Hospital — Seoul,
- Yonsei University Health System, Severance Hospital — Seoul,
- Asan Medical Center — Seoul,
- Samsung Medical Center — Seoul,
📞 Contact the Study Coordinator
Phone: (822) 404-2003
Email: Clinical-102@gi-innovation.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Solid Tumor
- Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression — Iowa City, Iowa
- A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors — Glendale, California
- QTX3046 in Patients With KRAS G12D Mutations — Grand Rapids, Michigan
- A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors — Houston, Texas
- First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer — Fullerton, California
- A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors — San Antonio, Texas
Explore by condition: All Advanced Solid Tumor clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.