Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04474470
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2020-06-30
Brief Title:
A Study to Evaluate NT219 Alone and in Combination with ERBITUX Cetuximab in Adults with Advanced Solid Tumors and Head and Neck Cancer
Sponsor:
TyrNovo Ltd
Organization:
Purple Biotech Ltd
Study Overview
Official Title:
A Phase 12 Study with Open-Label Dose Escalation Phase Followed by Single-Arm Expansion At the Maximum Tolerated Dose to Assess the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of NT219 Injection Alone and in Combination with ERBITUX Cetuximab in Adults with Advanced Solid Tumors and Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2024-05
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 is a phase 12 multi-center study with an open-label dose escalation phase followed by a single-arm expansion phase to assess the safety tolerability pharmacokinetics pharmacodynamics and efficacy of NT219 alone and in combination with ERBITUX cetuximab in adults with recurrent andor metastatic solid tumors
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