Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530914
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma
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 Randomized Phase II Study of MRG003 in Combination With Pucotenlimab Injection Cisplatin in Patients With Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma This proposed study will evaluate the efficacy and safety of preoperative administration of MRG003 in Combination With Pucotenlimab Injection Cisplatin in HNSCC who are eligible for resection
Detailed Description:
In this study eligible patients will be randomized in a 11 ratio to either the MRG003 Injection Combined With Pucotenlimab Injection treatment group Cohort 1 or the MRG003 Injection Combined With Pucotenlimab Injection Cisplatin treatment group Cohort 2 Pathological response rate 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