NCT07116824

HB1801 Combined Treatment of HER2-positive Breast Cancer

A Phase II Trial to Evaluate the Safety and Efficacy of HB1801 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	HB1801	HB1801 is administered by intravenous infusion.
DRUG	Trastuzumab	Trastuzumab is administered by intravenous infusion, 8mg/kg loading dose and then 6mg/kg per cycle, Q3W.
DRUG	Pertuzumab	Pertuzumab is administered by intravenous infusion, 840mg loading dose and then 420mg per cycle, Q3W.
DRUG	Docetaxel	Docetaxel is administered by intravenous infusion, 75mg/m\^2, Q3W.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-07-15
• Completion: 2027-11-07
• First posted: 2025-08-12
• Last updated: 2025-08-12