B002 in Patients With HER2-positive Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

May 28, 2019

Primary Completion Date

April 26, 2022

Study Completion Date

April 26, 2022

Conditions
Recurrent Breast CancerMetastatic Breast Cancer
Interventions
BIOLOGICAL

Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002.

Usage: intravenous infusion; B002, doses 2, 6, 12, 16, 20 mg / kg, intravenous drip. The infusion time was 120 ± 10 minutes for the first time; if the patient was tolerated, the follow-up time was adjusted to 60 ± 10 minutes. Pre-treatment was performed using phenergan (25 mg, intramuscular) within 30 minutes prior to each study drug infusion. The dosing cycle is administered once every 3 weeks for one cycle and can be administered continuously until the disease progresses or is intolerable.

Trial Locations (1)

200032

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY

NCT04382352 - B002 in Patients With HER2-positive Breast Cancer | Biotech Hunter | Biotech Hunter