Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608786
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-10-22
Brief Title:
A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer
Sponsor:
Lees Pharmaceutical Limited
Organization:
Lees Pharmaceutical Limited
Study Overview
Official Title:
A Single-arm Open-labelPhase Ib Clinical Study of ZKAB001 Combined With Capecitabine in Adjuvant Therapy for Patients With Biliary Tract Cancer After Radical Resection
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
ENROLLING_BY_INVITATION
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 is a Phase Ib open-labelsingle-arm clinical study aiming to investigate the safety tolerability and pharmacokinetics of ZKAB001 a fully human monoclonal antibody targeting the Programmed Death - Ligand 1 PD-L1 membrane receptor combined with capecitabine as adjuvant chemotherapy for patients with biliary tract cancers after radical resectionAfter completing 8 courses of combined treatment ZKAB001 was continued to be administered separately once 3 weeks for a total of 16 cycles or 1 year
Detailed Description:
This study includes two phasesthe first phase is the dose exploration 6 subjects were first included at the initial dose to confirm the dose safety If the toxicity is not tolerated the dose of the chemotherapeutic agent will be reduced depending on the toxicityincluding hematological toxicity and non-hematological toxicity for further exploration If it can be tolerated the recommended dose is determined and expanded on this dose the second phase is the dose expansion 4 subjects will be enrolled to further observe the safety and efficacy The DLTDose limited toxicity observation period is set as the first course of treatment3 weeks The end point is that the patient has been taking the drug for 16 cycles or 1 year or the patient dies or develops intolerable toxicity or confirmed disease recurrence or distant metastasis or withdrawal of informed consent
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