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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)
Conditions
Interventions
GI-101
Pembrolizumab (KEYTRUDA®)
+2 more
Locations
8
United States
Tisch Cancer Institute (TCI), Icahn School of Medicine
New York, New York, United States
Carolina Biooncology Institute
Huntersville, North Carolina, United States
Chungnam National University Hospital
Daejeon, Daejeon, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, Kyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Start Date
August 2, 2021
Primary Completion Date
June 30, 2028
Completion Date
June 30, 2028
Last Updated
March 17, 2026
NCT06157151
NCT07181681
NCT06257264
NCT07360314
NCT07403721
NCT07380334
Recruiting sites have contact information. Please contact the sites directly.
CONTACT
+8224042003clinical@gi-innovation.comLead Sponsor
GI Innovation, Inc.
Collaborators
Data Source & Attribution
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