Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04929080
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2021-05-10
Brief Title:
The Safety and Efficacy of Multiple-dose of JS004 in Subject With HNC
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Phase III Clinical Study of JS004 a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator BTLA in Subjects With Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2023-07
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:
A phase III clinical study of JS004 in subjects with head and neck cancer in China to evaluate the safety tolerability PK immunogenicity antitumor activity and biomarkers of JS004 define the RP2D A cycle is 21 days 3 weeks which includes JS004 being administered IV Q3W and JS004 combine with JS001 being administered IV Q3W All patients will be treated until disease progression per RECIST v11 and iRECIST or intolerable toxicity per CTCAE 50 withdrawal of consent or end of the study whichever occurs firstDisease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression
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