NCT04170595

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection

A Randomized, Multicenter, Phase I/IIa Clinical Study to Evaluate the Tolerability, Safety, Efficacy, Pharmacokinetics and Immunogenicity of GB221 for Injection for the Treatment of HER2-positive Breast Cancer Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Genor Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	GB221,2 mg/kg	Single dose, 2mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
BIOLOGICAL	GB221,6 mg/kg	Single dose 6mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
BIOLOGICAL	Herceptin,6 mg/kg	Single dose group: lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
BIOLOGICAL	GB221,8mg/kg	Single dose 8mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 8mg/kg for one dose, intravenous infusion, completed for over 90 minutes
BIOLOGICAL	GB221:2mg/kg and Capecitabi:1000mg/kg	GB221:Lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose group; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.
BIOLOGICAL	Herceptin:2mg/kg and Capecitabin:1000mg/kg	Herceptin:Lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose groups; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.

Timeline

• Start date: 2014-03-28
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2019-11-20
• Last updated: 2021-03-03

Locations

1 site across 1 country: China