Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05190575
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-12-28
Brief Title:
TST001 in Patients With CLDN182 Positive Previously Treated Advanced Biliary Tract Cancer
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
An Open-label Single-arm Phase II Study to Evaluate the Efficacy and Safety of TST001 for Patients With CLDN182 Positive Previously Treated Unresectable Advanced or Metastatic Biliary Tract Cancer
Status:
COMPLETED
Status Verified Date:
2021-12
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:
TST001 is a recombinant humanized anti-Claudin 182 CLDN182 IgG1 monoclonal antibody This is an open-label single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN182 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer
Detailed Description:
TST001 is a recombinant humanized anti-Claudin 182 CLDN182 IgG1 monoclonal antibody Claudin182 CLDN182 protein is one of the family of tetraspanning proteins expressed at epithelial tight junctions and primarily expressed only in normal gastric tissues CLDN182 protein is a pancancer target expressed in primary lesions and metastases of variouscancer types including gastric cancer biliary tract cancer and others Current available information indicates that CLDN182 is a promising therapeutic target for the treatment of solid tumors
This is an open-label single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN182 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer Eligible patients will be treated with TST001 until disease progression or other discontinuation criteria met If there is one objective response among the first 15 enrolled patients then the trial continues to enroll a total of 40 patients if not then the trial discontinues
This is an open-label single-arm phase II study to evaluate the efficacy and safety of TST001 for patients with CLDN182 positive previously treated unresectable advanced or metastatic Biliary Tract Cancer Eligible patients will be treated with TST001 until disease progression or other discontinuation criteria met If there is one objective response among the first 15 enrolled patients then the trial continues to enroll a total of 40 patients if not then the trial discontinues
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