Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT06214793
Status:
SUSPENDED
Last Update Posted:
2025-05-01
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC)
Sponsor:
Megan Kruse, MD
Organization:
Study Overview
Official Title:
A Phase II Study of Taletrectinib in Previously Treated Metastatic CDH1-mutated Invasive Lobular Cancer (ILC) of the Breast (TaCe)
Status:
SUSPENDED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Anheart acquired by Nuvation Bio; leadership not moving forward
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 evaluate the safety and tolerability of talectrectinib as treatment for Stage IV ILC with CDH1 mutation
Detailed Description:
Invasive lobular cancer (ILC) represents 10-15% of all breast cancers, up to 75% of ILCs carry a mutation in CDH1 gene which encodes for e-cadherin (ECAD), which is a cell adhesion glycoprotein. Preclinical data using patient derived xenografts have shown loss of ECAD due to CDH1 mutation is associated with an upregulation ROS1 activity, and ROS1 inhibitors have demonstrated synthetic lethality in CDH1-mutated cell lines. Taletrectinib is a novel ROS1/NTRK inhibitor with demonstrated activity in ROS1 mutated non-small cell lung cancer. The purpose of the trial is to estimate the activity of taletrectinib in previously treated CDH1-mutated metastatic breast ILC.
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?:
False
Is an FDA AA801 Violation?: