Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04278859
Status:
UNKNOWN
Last Update Posted:
2020-06-16
First Post:
2020-02-18
Brief Title:
Safety Tolerability and Pharmacokinetics of a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator BTLA for Injection in Subjects With Advanced Malignancies
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study of JS004 a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator BTLA in Subjects With Advanced Solid Malignancies
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
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 3-part dose-escalation dose-expansion and cohort-expansion phase I clinical study of JS004 in subjects with advanced solid malignancies in China for the first time to evaluate the safety tolerability PK immunogenicity antitumor activity and biomarkers of JS004 define the MTD and RP2D A cycle is 21 days 3 weeks which includes JS004 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