NCT07294508

A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

An Open-Label, Randomized, Multicenter, Phase II/III Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 706 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer

Detailed description

The study consists of two stages Stage I is an open-label, multicenter, randomized, parallel-controlled phase II clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on ORR and PFS results. Stage II is an open-label, multicenter, randomized, parallel-controlled phase III clinical study, and its primary objective is to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer based on PFS results.

Conditions

• HER2 + Breast Cancer

Interventions

Type	Name	Description
DRUG	HLX87 + HLX22	HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2 .
DRUG	HLX87 + Pertuzumab	HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan
DRUG	T-Dxd + Pertuzumab	T-Dxd is a HER2-targeted ADC
DRUG	THP	Pertuzumab+ Trastuzumab+Docetaxel

Timeline

• Start date: 2026-02-27
• Primary completion: 2028-01-15
• Completion: 2030-12-30
• First posted: 2025-12-19
• Last updated: 2026-03-20

Locations

1 site across 1 country: China