drugset / Trial / NCT05008510

P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC .

NCT05008510

Phase 2 Withdrawn Veru Inc.
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

EvaluationDrugModalityDoseRoute
Subject Sabizabulin Small molecule 32 mg Oral
Comparator Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous