drugset / Trial / NCT04608786

A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer

NCT04608786

Phase 1 Unknown 10 enrolled Lee's Pharmaceutical Limited
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase Ib, open-label,single-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 resection.After 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.

Timeline

Start
2021-02-01
Primary completion
2022-12-01
Completion
2023-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Socazolimab Monoclonal antibody 5 mg/kg Intravenous

Indications