NCT06612203

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an international, multicenter, open-label, single arm, phase Ib/II clinical trial to evaluate Debio 0123's RP2D when administered in combination with Sacituzumab govitecan, safety and efficacy of this combination therapy in advanced/metastatic breast cancer patients. Patients aged ≥ 18 years with TNBC or HR+/HER2- advanced/metastatic breast cancer relapsing after one or two lines of treatment are eligible to participate in the study. In the phase Ib of the study the investigators will recruit 12-24 patients with TNBC or HR+/HER2- advanced/metastatic breast cancer and the dose escalation will follow pre-defined dose levels, starting at DL1. In the phase II, 26 patients with advanced/metastatic TNBC and 26 patients with HR+/HER2- advanced/metastatic breast cancer will be treated with Debio 0123's RP2D plus 10 mg/kg of Sacituzumab govitecan. Patients will be treated until disease progression, discontinuation for any reason or study termination.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Debio 0123 and Sacituzumab govitecan	Debio 0123 will be administered orally during 6 days of each 21-day cycle in combination with 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle until documented disease progression, death, unacceptable toxicity, or discontinuation from the study treatment for any other reason, whichever occurs first.

Timeline

• Start date: 2025-01-17
• Primary completion: 2027-02-01
• Completion: 2027-10-01
• First posted: 2024-09-25
• Last updated: 2025-12-05

Locations

7 sites across 2 countries: Spain, United Kingdom