drugset / Trial / NCT04927884
A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies
NaSingle-groupOpen-labelTreatment
Summary
This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects with Triple Negative Breast Cancer (TNBC) after at least 2 prior treatments for metastatic disease.
Timeline
- Start
- 2021-09-08
- Primary completion
- 2022-09-13
- Completion
- 2022-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 25 mg | Oral |
| Background | N-803 | Protein / enzyme biologic | 15 ug/kg | Subcutaneous |
| Background | PD-L1 t-haNK | Cell therapy | 2e+09 cells | Intravenous |