Clinical Trial

Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer

Study acronym: WIN-B
Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-09-23; most recent amendment 2025-12-04.
Status change: Recruiting → Active, Not Recruiting 2025-12-04
Status change: Not Yet Recruiting → Recruiting 2025-01-22
Trial Details
NCT Number NCT06612203
Lead Sponsor MedSIR
Collaborators: Debiopharm International SA, Gilead Sciences
Conditions Advanced Breast Cancer
Enrollment 76 participants
Start Date 2025-01-17
Primary Completion 2027-02 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2025-12-05