NCT04382352

B002 in Patients With HER2-positive Breast Cancer

Experimental Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of B002 in the Treatment of HER2-positive Recurrent or Metastatic Breast Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and tolerability characteristics of B002 in patients with HER2-positive recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) was assessed and the maximum tolerated dose (MTD) was explored.

Conditions

• Recurrent Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-28
• Primary completion: 2022-04-26
• Completion: 2022-04-26
• First posted: 2020-05-11
• Last updated: 2023-03-24

Locations

1 site across 1 country: China