An Open-label, Dose-escalated, Phase I Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetic Profiles of GB222 in Chinese Patients With Relapsed/Progressive High-grade Glioma

Genor Biopharma Co., Ltd.1 site in 1 country24 target enrollmentOctober 16, 2018

ConditionsBrain Tumor

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Brain Tumor
Sponsor: Genor Biopharma Co., Ltd.
Enrollment: 24
Locations: 1
Primary Endpoint: Dose-limiting toxicity, DLT
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to assess the safety and tolerability, pharmacokinetic profiles, immunogenicity of GB222 in Chinese patients with relapsed/progressive high-grade glioma; moreover, changes in cerebral edema, changes in KPS score from baseline, objective response rate (ORR), 4-month progression-free survival (PFS), overall survival (OS)will be evaluated. The dose reduction of hormone during continuous administration period will be observed.

Registry

clinicaltrials.gov

Start Date

October 16, 2018

End Date

April 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genor Biopharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patients can be enrolled only if they meet the following all inclusion criteria:
•Age ≥ 18 years, male or female;
•Understand the study procedures and contents, and voluntarily sign the written informed consent form;
•Histologically or cytologically confirmed advanced high-grade glioma which failed respond to conventional treatment and is unsuitable to receive multidisciplinary treatment, WHO grades III-IV;
•Disease progression (recurrence) after first-line treatment including surgery, radiotherapy and temozolomide chemotherapy;
•MRI confirmed tumor progression (within 14 days before the administration of investigational product);
•KPS score ≥50;
•Life expectancy≥3 months;
•The resection of relapsed brain tumors is performed at least 4 weeks before the use of investigational products, or sereotactic mamography biopsy of brain tumors is performed at least 2 weeks before the use of investigational products;
•The radiotherapy is performed at least 12 weeks before the use of investigational products, unless that the size increased of relapsed tumor is larger than that of the site received radiotherapy or histologically confirmed tumor progression;