30
Participants
Start Date
April 1, 2019
Primary Completion Date
January 13, 2023
Study Completion Date
January 13, 2023
Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.
"Usage: Intravenous infusion; Dose escalation stage: doses 0.6, 1.2, 2.4, 3.6, 4.8 mg / kg, 1-6subjects each. Dose expansion stage: 20 subjects are enrolled and take the recommended dose based on the result of dose escalation stage.~Infusion time:90 minutes(90min-106min suggested) for the first time; if no infusion reaction happens, the follow-up time is adjusted to at least30 minutes(30min-40min suggested).Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is the 21st day of the first treatment cycle."
West China Hospital of Sichuan University, Chengdu
Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY