Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449222
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-03
Brief Title:
Safety and Preliminary Effectiveness of BNT327 an Investigational Therapy for Breast Cancer When Given in Combination With Chemotherapy
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
A Phase II Multi-site Randomized Open-label Clinical Trial to Evaluate the Safety Efficacy and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This study is a Phase II multi-site randomized open-label clinical study to evaluate the safety efficacy and pharmacokinetics PK of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advancedmetastatic triple-negative breast cancer mTNBC
Detailed Description:
Participants will be treated until disease progression intolerable toxicity participant withdrawal study termination or up to 2 years whichever occurs first
Study Oversight
Has Oversight DMC:
None
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?:
None