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

NCT04164615 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2019-11-15

No results posted yet for this study

Summary

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.

Conditions

  • HER-2-positive Advanced Breast Cancer

Interventions

DRUG

GB221

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.

DRUG

Placebo control

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.

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-24
Primary Completion
2020-07-31
Completion
2020-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04164615 on ClinicalTrials.gov