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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 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04261439
The ClinicalTrials.gov registry entry for NCT04261439 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Tislelizumab is the first listed.
NCT04261439 reports 0 study locations.
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.
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