NCT04178057

Phase I Clinical Study of GB222 to Evaluate the Safety, Tolerability and PK Profiles.

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Tumor

Interventions

Type	Name	Description
BIOLOGICAL	GB222 3mg/kg	Injection, strength 100mg/bottle, intravenous infusion, 3mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; low dose group.
BIOLOGICAL	GB222 5mg/kg	Injection, strength 100mg/bottle, intravenous infusion,5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 1.
BIOLOGICAL	GB222 7.5mg/kg	Injection, strength 100mg/bottle, intravenous infusion,7.5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 2.
BIOLOGICAL	GB222 10mg/kg	Injection, strength 100mg/bottle, intravenous infusion,10mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; high dose group.

Timeline

• Start date: 2018-10-16
• Primary completion: 2020-12-01
• Completion: 2021-04-01
• First posted: 2019-11-26
• Last updated: 2019-11-27

Locations

1 site across 1 country: China