NCT04608786

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

A Single-arm, Open-label，Phase Ib Clinical Study of ZKAB001 Combined With Capecitabine in Adjuvant Therapy for Patients With Biliary Tract Cancer After Radical Resection

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes two phases,the 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 toxicity(including 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 DLT(Dose limited toxicity) observation period is set as the first course of treatment(3 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.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	ZKAB001 5mg/kg	ZKAB001 D1 IV 5mg/kg every three weeks,up to 16 cycles or 1 year
DRUG	Capecitabine	Capecitabine po 1000mg / m2/time, 2 times/d for 2 weeks, followed by 1 week of stopping ,three weeks is a course of treatment with a total of 8 courses

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-10-29
• Last updated: 2022-01-11

Locations

1 site across 1 country: China