Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
NCT04000529 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 122
Last updated 2025-09-30
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.
Conditions
- Non-small Cell Lung Carcinoma
- Head and Neck Squamous Cell Carcinoma
- Esophageal SCC
- Gastrointestinal Stromal Tumors
- Colorectal Cancer
Interventions
- DRUG
-
TNO155
Capsule
- DRUG
-
Spartalizumab
Concentrate for solution for infusion
- DRUG
-
Capsule and tablet
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-30
- Primary Completion
- 2024-01-15
- Completion
- 2024-01-15
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- China
- Germany
- Hong Kong
- Japan
- Singapore
- Spain
Study Locations
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