Viewing Study NCT04880863



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