B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

January 13, 2023

Study Completion Date

January 13, 2023

Conditions
HER2-positive Breast Cancer
Interventions
BIOLOGICAL

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."

Trial Locations (1)

Unknown

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
lead

Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY

NCT03953833 - B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter