Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Immunoglobulins

Antineoplastic Agents, Immunological

6 mg/kg, single dose, intravenous infusion, 90-100 min

GB221

Herceptin

This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.

Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.

Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers

compare the pharmacokinetic AUC0-t parameters of GB221 and Herceptin ®

compare the pharmacokinetic AUC0-∞parameters of GB221 and Herceptin ®

compare the pharmacokinetic Cmax parameters of GB221 and Herceptin ®

compare the pharmacokinetic Tmax parameters of GB221 and Herceptin ®

compare the pharmacokinetic t1/2 parameters of GB221 and Herceptin ®

compare the pharmacokinetic CL parameters of GB221 and Herceptin ®

compare the pharmacokinetic Vd parameters of GB221 and Herceptin ®

compare the pharmacokinetic Ke parameters of GB221 and Herceptin ®

compare the incidence of ADA in of GB221 and Herceptin ® group

compare the incidence of Nab in of GB221 and Herceptin ® group

Genor Biopharma Co., Ltd.

Capecitabine

Antimetabolites

GB221:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30\~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.

Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.

Placebo control:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30\~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.

Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.

Placebo control

Shawn Yu, Master

Ze Fei Jiang, Ph.D

The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from treatment period to week 12; overall survival (OS), safety, immunogenicity (anti-drug antibody), PFS of subjects during continued treatment period.

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection

A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer

To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.

To evaluate the efficacy of GB221 as defined by overall response rate, in patients with breast cancer.

To evaluate the duration from the first administration to death because of any reason in patients with breast cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®	NCT04905667	Breast Cancer	GB221 Herceptin	18 Years - 45 Years	Genor Biopharma Co., Ltd.
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection	NCT04164615	HER-2-positive ...	GB221 Placebo control	18 Years - 70 Years	Genor Biopharma Co., Ltd.
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection	NCT04164615	HER-2-positive ...	GB221 Placebo control	18 Years - 70 Years	Genor Biopharma Co., Ltd.
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®	NCT04905667	Breast Cancer	GB221 Herceptin	18 Years - 45 Years	Genor Biopharma Co., Ltd.

Spots Global Cancer Trial Database for gb221

Every month we try and update this database with for gb221 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gb221

Every month we try and update this database with for gb221 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gb221 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.