NCT04000529

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

A Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rationale The purpose of this study was to evaluate the safety, tolerability, and preliminary efficacy of the combination of TNO155 with spartalizumab and of TNO155 with ribociclib, and to identify dosing regimens for further study. Data from preclinical models have demonstrated anti-tumor activity for the combinations of TNO155 with spartalizumab and of TNO155 with ribociclib that is superior to the activity observed with each of the drugs as single agents. These data suggest that these combinations may provide clinical benefit to patients with advanced malignancies. Study Design This study was a Phase Ib, multi-center, open-label study with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors to characterize the safety and tolerability TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib and to identify the MTD and/or recommended regimen (dose and schedule) for each combination. 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. Objectives Primary objective: To characterize the safety and tolerability TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib, and to identify the MTD and/or recommended regimen (dose and schedule) for each combination. Secondary objectives: * To characterize the pharmacokinetic (PK) profile of TNO155, spartalizumab and ribociclib when administered as a combination of TNO155 plus spartalizumab or of TNO155 plus ribociclib. * To evaluate the preliminary anti-tumor activity of TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib.

Conditions

• Non-small Cell Lung Carcinoma
• Head and Neck Squamous Cell Carcinoma
• Esophageal SCC
• Gastrointestinal Stromal Tumors
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TNO155	Capsule
DRUG	Spartalizumab	Concentrate for solution for infusion
DRUG	Ribociclib	Capsule and tablet

Timeline

• Start date: 2019-07-30
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2019-06-27
• Last updated: 2025-09-30

Locations

10 sites across 9 countries: United States, Australia, Belgium, China, Germany, Hong Kong, Japan, Singapore, Spain

Regulatory

• FDA-regulated drug study