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NCT04261439 · ClinicalTrials.gov registry record · Phase 1
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT04261439: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT04261439 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04261439, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for further study. Moreover, the study characterized the pharmacokinetic profiles of NIZ985 as a single agent and in combination with spartalizumab or tislelizumab and identified preliminary anti-tumor activity.
Primary Outcome
Incidence of DLTs in Cycle 1 (28 days) in escalation and expansion
Interventions
- DRUG Tislelizumab
- DRUG Spartalizumab
- DRUG NIZ985
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2023-12-27 |
| Phase | Phase 1 |
Why NCT04261439 stopped before completion
NCT04261439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Tislelizumab is the first listed.
NCT04261439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04261439 about?
NCT04261439 is a clinical study titled "A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab". The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for further study. Moreover, the study characterized the pharmacokinetic prof...
What is the current status of trial NCT04261439?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2020-02-27. Estimated completion is 2023-12-27.
What interventions are being tested in trial NCT04261439?
The interventions under investigation include: Tislelizumab (DRUG), Spartalizumab (DRUG), NIZ985 (DRUG).
Who is sponsoring clinical trial NCT04261439?
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 NCT04261439's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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