Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04610528
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-23
First Post:
2020-10-27
Brief Title:
A Window-of-opportunity Study of U3-1402 a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression
Sponsor:
SOLTI Breast Cancer Research Group
Organization:
SOLTI Breast Cancer Research Group
Study Overview
Official Title:
A Window-of-opportunity Study of U3-1402 a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
TOT-HER3
Brief Summary:
This is a prospective multicenter single arm window-of-opportunity study evaluating the biological effect of U3-1402 in treatment naïve patients with early breast cancer whose primary tumors are 1 cm by ultrasound evaluation
The primary objective is to evaluate the biological activity of U3-1402 measured as the CelTIL score increase at post-treatment C1D21 in HRHER2-negative BC included patients
The study will consist of 2 parts enrolling 115 patients
Part A will target to treat with 64 mgkg dose 80 patients with HR-positiveHER2-negative tumors and
Part B will target to treat with 56 mgkg dose 20 patients with HR-positiveHER2-negative and 15 patients with TNBC tumors
Part A will test U3-1402 in patients with HR-positiveHER2-negative early breast cancer with a dose of 64 mgkg Part B will consist in testing 56 mgkg dose of U3-1402 in patients with HR-positiveHER2-negative early breast cancer and in triple-negative early breast cancer and will be performed sequentially after Part A
The primary objective is to evaluate the biological activity of U3-1402 measured as the CelTIL score increase at post-treatment C1D21 in HRHER2-negative BC included patients
The study will consist of 2 parts enrolling 115 patients
Part A will target to treat with 64 mgkg dose 80 patients with HR-positiveHER2-negative tumors and
Part B will target to treat with 56 mgkg dose 20 patients with HR-positiveHER2-negative and 15 patients with TNBC tumors
Part A will test U3-1402 in patients with HR-positiveHER2-negative early breast cancer with a dose of 64 mgkg Part B will consist in testing 56 mgkg dose of U3-1402 in patients with HR-positiveHER2-negative early breast cancer and in triple-negative early breast cancer and will be performed sequentially after Part A
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004964-23 | EUDRACT_NUMBER | None | None |