Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-01-01 @ 5:14 AM
Study NCT ID:
NCT04461600
Status:
TERMINATED
Last Update Posted:
2024-02-12
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer
Sponsor:
Ayala Pharmaceuticals, Inc,
Organization:
Study Overview
Official Title:
A Phase 2, Multi-center, Open-label, Single Arm Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor's decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENACITY
Brief Summary:
The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: