Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04880863
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2021-05-03
Brief Title:
Naptumomab Estafenatox NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC
Sponsor:
NeoTX Therapeutics Ltd
Organization:
NeoTX Therapeutics Ltd
Study Overview
Official Title:
Phase 2a Open-Label Multicenter Trial of Naptumomab Estafenatox NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NT-NAP-102-1
Brief Summary:
Phase 2a Open-Label Multicenter Trial of Naptumomab Estafenatox NAP following Obinutuzumab Pretreatment on Days -13 and -12 NAP will be administered on Days 1-4 of treatment cycles 1-6 followed by docetaxel on Day 5 Starting cycle 7 NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2 in 21 days treatment cycles When NAP is administered as monotherapy and not earlier than cycle 7 NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle
Detailed Description:
None
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