drugset / Trial / NCT04261439
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-02-27
- Primary completion
- 2023-12-27
- Completion
- 2023-12-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NIZ985 | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Spartalizumab | Monoclonal antibody | — | — |
| Subject | Tislelizumab | Monoclonal antibody | — | — |