Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2026-01-01 @ 10:05 AM
Study NCT ID:
NCT03983395
Status:
TERMINATED
Last Update Posted:
2021-05-24
First Post:
2019-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer
Sponsor:
Ichnos Sciences SA
Organization:
Study Overview
Official Title:
A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated during Part 1 (dose escalation), and Part 2 (expansion) of the study was not initiated. This study was voluntarily terminated due to a business decision not to proceed with the ISB 1302 asset, and not due to any safety issue.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.
Detailed Description:
To determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB 1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IND Number 131316 | OTHER | FDA | View |