Clinical Trial

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors

Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 1 change
notable Trial sites expanded: 8 -> 12 locations 2026-05-16
Trial Details
NCT Number NCT04977453
Lead Sponsor GI Innovation, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Solid Tumor, Metastatic Solid Tumor, Cervical Cancer, Urothelial Carcinoma, Clear Cell Renal Cell Cancer (ccRCC), Squamous Cell Non Small Cell Lung Cancer
Enrollment 317 participants
Start Date 2021-08-02
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-15