drugset / Trial / NCT04977453

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

NCT04977453

Phase 1/2 Recruiting 317 enrolled GI Innovation, Inc. Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2021-08-02
Primary completion
2028-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject GI-101 Protein / enzyme biologic Intravenous
Subject GI-101A Protein / enzyme biologic Intravenous
Background Lenvatinib Small molecule Oral
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous