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

PHASE1UnknownINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 16, 2018

Primary Completion Date

December 31, 2020

Study Completion Date

April 30, 2021

Conditions
Brain Tumor
Interventions
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.

Trial Locations (1)

100050

RECRUITING

Beijing Tiantan Hospital of Capital Medical University, Beijing

Sponsors
All Listed Sponsors
lead

Genor Biopharma Co., Ltd.

INDUSTRY