GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors (NCT04977453)
A Phase 1/2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101/GI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.
Who can join: Review the eligibility criteria below.
Location: Tisch Cancer Institute (TCI), Icahn School of Medicine — New York, New York
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 (12 Sites)
- Tisch Cancer Institute (TCI), Icahn School of Medicine — New York, New York
- Carolina Biooncology Institute — Huntersville, North Carolina
- The Catholic University of Korea Seoul ST.MARY'S Hospital — Seoul, Banpo-daero
- Seoul National University Bundang Hospital — Seoul, Bundang-gu
- Chungnam National University Hospital — Daejeon, Daejeon
- Samsung Medical Center — Seoul, Gangnam
- The Catholic University of Korea St. Vincent's Hospital — Suwon, Kyeonggi-do
- Korea University Anam Hospital — Seoul, Seongbuk-gu
- Ewha Womans University Mokdong Hospital — Seoul, Yangcheon-gu
- Yonsei University Health System, Severance Hospital — Seoul,
- Yonsei University Health System, Severance Hospital — Seoul,
- Asan Medical Center — Seoul,
📞 Contact the Study Coordinator
Phone: (822) 404-2003
Email: clinical@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.