NCT03676946 is a Phase 1, PHASE2 clinical trial of ZKAB001 5mg/kg in Urothelial Carcinoma, sponsored by Lee's Pharmaceutical Limited.

Who is sponsoring NCT03676946?

NCT03676946 is sponsored by Lee's Pharmaceutical Limited.

What drugs are being tested in NCT03676946?

Interventions in NCT03676946: ZKAB001 5mg/kg, ZKAB001 10mg/kg, ZKAB001 15mg/kg.

What condition does NCT03676946 study?

NCT03676946 studies Urothelial Carcinoma.

Is NCT03676946 still recruiting?

NCT03676946 is currently status unknown. Last updated 26 September 2018.

Last reviewed 2018-09-26 · How we verify

NCT03676946

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study of PD-L1 Antibody ZKAB001（Drug Code） in Locally Advanced and Metastatic Urothelial Carcinoma

Status unknown Phase 1, PHASE2 Last updated 26 September 2018

What this trial tests

Phase 1, PHASE2 trial testing ZKAB001 5mg/kg in Urothelial Carcinoma in 15 participants. Status unknown.

Timeline

10 October 2018

Primary endpoint
14 February 2020

23 June 2023

Quick facts

Lead sponsor	Lee's Pharmaceutical Limited
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	10 October 2018
Primary completion	14 February 2020
Estimated completion	23 June 2023
Sites	1 location across China

Drugs / interventions tested

ZKAB001 5mg/kg — full drug profile →
ZKAB001 10mg/kg — full drug profile →
ZKAB001 15mg/kg — full drug profile →

Conditions studied

Urothelial Carcinoma — all drugs for Urothelial Carcinoma →

Sponsor

Lee's Pharmaceutical Limited — full company profile →

Who can join

Adults 18 to 75, any sex, with Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1+2, open-label, dose-escalation, and multidose 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 on T lymphocytes and other cells of the immune system) administered every 14 days in subjects with locally advanced and metastatic urothelial carcinoma.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Metastatic Urothelial Cancer: a rapidly changing treatment landscape.
Stecca C, Abdeljalil O, Sridhar SS. · · 2021 · cited 40× · PMID 34616491 · DOI 10.1177/17588359211047352
A Comprehensive Review of Immunotherapy Clinical Trials for Metastatic Urothelial Carcinoma: Immune Checkpoint Inhibitors Alone or in Combination, Novel Antibodies, Cellular Therapies, and Vaccines.
Patel DM, Mateen R, Qaddour N, Carrillo A, et al · · 2024 · cited 13× · PMID 38254823 · DOI 10.3390/cancers16020335

Verify or expand the search:

Other trials of ZKAB001 5mg/kg

Trials testing the same drug.

NCT04608786 — A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer · Phase 1 · unknown
NCT03676985 — A Clinical Study of PD-L1 Antibody ZKAB001(Drug Code) in Limited Stage of High-grade Osteosarcoma · Phase 1, PHASE2 · unknown
NCT03676959 — A Clinical Study of PD-L1 Antibody ZKAB001（Drug Code） in Recurrent or Metastatic Cervical Cancer · Phase 1 · unknown

Other recruiting trials for Urothelial Carcinoma

Currently open trials in the same condition.

NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07421700 — Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer · Phase 1, PHASE2 · recruiting
NCT07492628 — Dual-Target Nectin-4/HER2 CAR-NK Cells in Advanced Urothelial Carcinoma · Phase 1 · recruiting
NCT07390617 — A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma · recruiting

Other Lee's Pharmaceutical Limited trials

Trials by the same sponsor.

NCT06953453 — A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors · Phase 1 · recruiting
NCT07099144 — Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension · recruiting
NCT06459687 — Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer · Phase 3 · recruiting
NCT06374485 — Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment · Phase 1 · recruiting
NCT05806918 — Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient M · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03676946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lee's Pharmaceutical Limited
Last refreshed: 26 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03676946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing