Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 2:09 PM
Study NCT ID:
NCT06612203
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
Sponsor:
MedSIR
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WIN-B
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: