Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629597
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Multicenter Phase III Clinical Study of YL201 Versus Investigators Choice of Chemotherapy in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-L1 Inhibitor and at Least Two Lines of Chemotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This study was designed to compare the efficacy and safety of YL201 with Investigators choice of chemotherapy in subjects with recurrent or metastatic nasopharyngeal carcinoma who have failed prior PD-L1 inhibitor and at least two lines of chemotherapy
Detailed Description:
The primary objective of this study is to assess whether treatment with YL201 prolongs overall survival OS and increases objective response rate ORR by blinded independent central review BICR compared with treatment of investigators choice of chemotherapy among subjects with recurrent or metastatic nasopharyngeal carcinoma
The secondary objectives of the study are to further evaluate the efficacy safety pharmacokinetics and immunogenicity of YL201 and the correlation between B7-H3 expression level and the efficacy of YL201
The secondary objectives of the study are to further evaluate the efficacy safety pharmacokinetics and immunogenicity of YL201 and the correlation between B7-H3 expression level and the efficacy of YL201
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