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A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive

NCT03808857 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-03-03

No results posted yet for this study

Summary

This study is a multi-center, prospective, open-label, single-arm phase II clinical study to evaluate the efficacy, safety and immunogenicity of GB226 in treatment of recurrent or metastatic cervical cancer patients with PD-L1 positive who failed in platinum-based chemotherapy.

Conditions

Interventions

BIOLOGICAL

GB226

GB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml\~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lingying Wu, Doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2021-12-31
Completion
2022-07-31

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 NCT03808857 on ClinicalTrials.gov