NCT05334810

DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastaticbreast Cancer

A Multi-center, Open-lable, Single-arm Phase II Study to Evaluate the Efficacy and Safety of DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 191 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study of DP303c in patients with HER2-positive advanced breast cancer.

Detailed description

This is a multi-center, open-lable, single-arm Phase II study to evaluate the efficacy and safety of DP303c in patients with HER2-positive unresectable locally advanced, relapsed, or metastatic breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg every 3 weeks. Patients will receive DP303c until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	DP303c	DP303c injection, 3.0 mg/kg, every 3 weeks.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-04-19
• Last updated: 2022-04-19