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A Clinical Study of PD-L1 Antibody ZKAB001（Drug Code） in Recurrent or Metastatic Cervical Cancer

NCT03676959 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-05-13

No results posted yet for this study

Summary

This is a Phase 1, open-label, dose-escalation, and multidose study, aiming to investigate the safety, tolerability and pharmacokinetics(PK) 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 recurrent or metastatic cervical cancer.

Conditions

Interventions

DRUG

ZKAB001 5mg/kg

5mg/kg/times bi-week IV administration of ZKAB001

DRUG

ZKAB001 10mg/kg

10mg/kg/times bi-week IV administration of ZKAB001

DRUG

ZKAB001 15mg/kg

15mg/kg/times bi-week IV administration of ZKAB001

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • lingying Wu, M.D · Tumor Hospital of the Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2022-05-15
Completion
2022-10-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03676959 on ClinicalTrials.gov