Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509997
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
A Phase II Study of Anti-EGFR Antibody-drug Conjugate ADC Combine With CDK46 Inhibitors Posterior Line in the Treatment of RecurrentMetastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MRG003 Combined With Dalpicicilip Posterior Line in the Treatment of RecurrentMetastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma A Phase II Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
A Single-arm Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrentmetastatic CDKN2A gene variant head and neck squamous cell carcinoman HNSCC The objective of this study was to evaluate the safety and efficacy of MRG003 combined with the Dalpicicilip posterior line in the treatment of recurrentmetastatic CDKN2A gene variant HNSCC
Detailed Description:
In this study patients meeting the inclusion criteria were given MRG003 D1 IVGTT Q3W in combination with Darcilil D1-21 PO Q4W after completing the relevant pre-treatment examination until progression or intolerable toxicity occurred Objective response rate and safety will be the primary outcome measures Adverse events will also be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None