drugset / Trial / NCT04787042
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multiphase, multicenter study, which includes a Phase 1a open-label, dose escalation monotherapy study of ST-067 given as an SC injection with or without obinutuzumab \[Gazyva®\] pre-treatment, by IV infusion, and in combination with pembrolizumab. A Phase 2 monotherapy arm is also planned; the exact design of the Phase 2 study elements with respect to formulation and pre-treatment will be determined after completion of the Phase 1 study portion of the trial.
Timeline
- Start
- 2021-08-06
- Primary completion
- 2025-06-30
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vevoctadekin | Protein / enzyme biologic | 30 ug/kg | Subcutaneous |
| Subject | Vevoctadekin | Protein / enzyme biologic | 60 ug/kg | Subcutaneous |
| Subject | Vevoctadekin | Protein / enzyme biologic | 120 ug/kg | Subcutaneous |
| Background | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | — |