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NCT04000529 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT04000529: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT04000529 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04000529, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study 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.
Primary Outcome
Incidence of dose limiting toxicities (DLTs) during the first cycle of combination treatment during the dose escalation part
Interventions
- DRUG Ribociclib
- DRUG Spartalizumab
- DRUG TNO155
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2024-01-15 |
| Phase | Phase 1 |
Why NCT04000529 stopped before completion
NCT04000529 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 3 interventions - of which Ribociclib is the first listed.
NCT04000529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04000529 about?
NCT04000529 is a clinical study titled "Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies". 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 ...
What is the current status of trial NCT04000529?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2019-07-30. Estimated completion is 2024-01-15.
What interventions are being tested in trial NCT04000529?
The interventions under investigation include: Ribociclib (DRUG), Spartalizumab (DRUG), TNO155 (DRUG).
Who is sponsoring clinical trial NCT04000529?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04000529's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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