drugset / Trial / NCT05008510
P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .
RandomizedParallel-groupSingle-blindTreatment
Summary
To compare the following: 1. The efficacy of sabizabulin monotherapy to sacituzumab govitecan-hziy monotherapy 2. The efficacy of sacituzumab govitecan-hziy/sabizabulin combination therapy to sacituzumab govitecan-hziy monotherapy These comparisons will be made in the efficacy in the treatment of metastatic triple negative breast cancer (mTNBC) in patients previously treated with at least two systemic chemotherapies for metastatic disease as measured by radiographic progression free survival (rPFS) as the primary endpoint.
Timeline
- Start
- 2021-12-30
- Primary completion
- 2022-07-30
- Completion
- 2023-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sabizabulin | Small molecule | 32 mg | Oral |
| Comparator | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |