drugset / Trial / NCT06612203
Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
Phase 1/2
Active not recruiting
76 enrolled
MedSIR
Debiopharm International SA · collabGilead Sciences · collab
NaSingle-groupOpen-labelTreatment
Summary
The WIN-B is an international, multicenter, single-arm, phase Ib/II study to evaluate the safety and activity of the Debio 0123 and Sacituzumab govitecan combination therapy in patients with pre-treated advanced/metastatic TNBC or HR+/HER2- breast cancer. Phase Ib will explore if the addition of increasing doses of Debio 0123 to Sacituzumab govitecan is safe and active in pre-treated advanced/metastatic TNBC and HR+/HER2- breast cancer patients. The Debio 0123's recomendad phase 2 doses (RP2D) obtained during phase Ib will then be administered in combination with Sacituzumab govitecan in phase II of the study.
Timeline
- Start
- 2025-01-17
- Primary completion
- 2027-02
- Completion
- 2027-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Debio 0123 | Unknown | — | Oral |
| Background | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |