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

Stopped early · Phase 1

Conditions studied: Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal SCC, Gastrointestinal Stromal Tumors, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04000529

Run by

Novartis Pharmaceuticals

People needed

122

Starts

2019-07-30

Expected to finish

2024-01-15

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Chengdu, Sichuan, China
• Novartis Investigative Site — Cologne, Germany
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain

Full record on ClinicalTrials.gov

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