Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612203
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Clinical Study to Evaluate Debio0123 Sacituzumab Govitecan Combination in TNBC or HRHER2- Advanced Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase IbII Study to Evaluate Safety and Preliminary Efficacy of the Wee1 Inhibitor Debio 0123 in Combination With Sacituzumab Govitecan in Triple-negative or HRHER2- Advanced Metastatic Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 IbII study to evaluate the safety and activity of the Debio 0123 and Sacituzumab govitecan combination therapy in patients with pre-treated advancedmetastatic TNBC or HRHER2- 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 advancedmetastatic TNBC and HRHER2- breast cancer patients The Debio 0123s 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 IbII clinical trial to evaluate Debio 0123s RP2D when administered in combination with Sacituzumab govitecan safety and efficacy of this combination therapy in advancedmetastatic breast cancer patients Patients aged 18 years with TNBC or HRHER2- advancedmetastatic 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 HRHER2- advancedmetastatic breast cancer and the dose escalation will follow pre-defined dose levels starting at DL1 In the phase II 26 patients with advancedmetastatic TNBC and 26 patients with HRHER2- advancedmetastatic breast cancer will be treated with Debio 0123s RP2D plus 10 mgkg 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 HRHER2- advancedmetastatic breast cancer and the dose escalation will follow pre-defined dose levels starting at DL1 In the phase II 26 patients with advancedmetastatic TNBC and 26 patients with HRHER2- advancedmetastatic breast cancer will be treated with Debio 0123s RP2D plus 10 mgkg of Sacituzumab govitecan Patients will be treated until disease progression discontinuation for any reason or study termination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None