Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456892
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Phase III Clinical Study on the Safety and Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen as Neoadjuvant Therapy for Children and Adolescents With IntermediateHigh-Risk Rhabdomyosarcoma
Status:
RECRUITING
Status Verified Date:
2024-06
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 study comprises both Phase I and Phase II research This phase focuses on safety tolerability and pharmacokinetics using a 33 dose escalation design with three dose groups 1 mgkg 3 mgkg and 6 mgkg The drug will be administered in combination with the standard regimen for intermediatehigh-risk rhabdomyosarcoma once every three weeks Q3W In phase II study all subjects will receive Pucotenlimab combined with the standard regimen for intermediatehigh-risk rhabdomyosarcoma for 2-4 cycles of neoadjuvant therapy every 3 weeks Q3W followed by surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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