drugset / Trial / NCT04000529

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

NCT04000529

Phase 1 Terminated 122 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Timeline

Start
2019-07-30
Primary completion
2024-01-15
Completion
2024-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject BATOPROTAFIB Small molecule
Subject Ribociclib Small molecule
Subject Spartalizumab Monoclonal antibody