Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04965766
Status:
RECRUITING
Last Update Posted:
2023-05-18
First Post:
2021-06-03
Brief Title:
Patritumab Deruxtecan U3-1402 in Unresectable Locally Advanced or Metastatic Breast Cancer
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Phase 2 Open Label Study of Patritumab Deruxtecan U3-1402 an Anti-HER3-Antibody Drug Conjugate ADC in Patients With Advanced Breast Cancer With Biomarker Analyses to Characterize Response to Therapy
Status:
RECRUITING
Status Verified Date:
2023-05
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:
ICARUS-BREAST
Brief Summary:
This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer ABC Participants have to be hormone-receptor positive HR and have to be resistant to endocrine therapy and cyclin-dependent kinases 4 and 6 CDK46 inhibitors Participants may have received multiple lines of endocrine therapy with or without targeted therapies and must have received only one line of chemotherapy for ABC
Moreover the immune effects the predictors of resistance and response to treatment the effect of the chemotherapy on deoxyribonucleic acid DNA replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment The pharmacokinetics of the product and the anti-drug antibody ADA will be also evaluated
A total of 100 participants are planned to be treated in the study Participants will receive every three weeks a dose of U3-1402 equivalent to 56 mgkg of body weight until progression or until unacceptable toxicity
Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax abdomen and pelvis TAP CT-scan or a magnetic resonance imaging MRI Brain andor bone CT scans will be also performed throughout the study for participants with brain andor bone metastasis
The safety of the product will be assessed at each cycle through complete clinical exams biological tests electrocardiograms ECGs cardiac echographies ECHOs and through the collection of ongoing toxicities or adverse events
Moreover the immune effects the predictors of resistance and response to treatment the effect of the chemotherapy on deoxyribonucleic acid DNA replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment The pharmacokinetics of the product and the anti-drug antibody ADA will be also evaluated
A total of 100 participants are planned to be treated in the study Participants will receive every three weeks a dose of U3-1402 equivalent to 56 mgkg of body weight until progression or until unacceptable toxicity
Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax abdomen and pelvis TAP CT-scan or a magnetic resonance imaging MRI Brain andor bone CT scans will be also performed throughout the study for participants with brain andor bone metastasis
The safety of the product will be assessed at each cycle through complete clinical exams biological tests electrocardiograms ECGs cardiac echographies ECHOs and through the collection of ongoing toxicities or adverse events
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 |
|---|---|---|---|
| 20203188 | OTHER | CSET number | None |