Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT06612203
Brief 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.
Study:
NCT06612203
Study Brief:
Protocol Section:
NCT06612203