drugset / Trial / NCT03752723

Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)

NCT03752723

Phase 1/2 Completed 84 enrolled Genexine, Inc. Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed TNBC

Timeline

Start
2019-03-27
Primary completion
2023-05-11
Completion
2023-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified Intravenous
Subject NT-I7 Protein / enzyme biologic Intramuscular
Subject Pembrolizumab Monoclonal antibody Intravenous