Phase Ib/II Study to Evaluate Safety and Preliminary Efficacy of the Wee1 Inhibitor Debio 0123 in Combination With Sacituzumab Govitecan in Triple-negative or HR+/HER2- Advanced/ Metastatic Breast Cancer (WIN-B)

NCT06612203 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	MedSIR
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	76
Start date	2025-01-17
Completion	2027-10

Conditions

• Advanced Breast Cancer

Interventions

• Debio 0123 and Sacituzumab govitecan

Primary outcomes

• Phase Ib - Debio 0123's recommended phase II dose (RP2D) when administered in combination with Sacituzumab govitecan in patients with TNBC or HR+/HER2- metastatic breast cancer. — Baseline up to 42 days.
  The RP2D of Debio 0123 when used in combination with Sacituzumab govitecan will be determined based upon evaluation of dose-limiting toxicities (DLTs), adverse events (AEs) and other available data from secondary endpoints.
• Phase II - Efficacy in terms of objective response rate (ORR) as per RECIST v.1.1 in each cohort. — Approximately 9 months from baseline.
  ORR, defined as the rate of patients with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1 in patients with TNBC and HR+/HER2- advanced/metastatic breast cancer.

Countries

Spain, United Kingdom