Trial Profile

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: Not yet recruiting

Phase of Trial: Phase II/III

Latest Information Update: 25 Dec 2025

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At a glance

Drugs GQ 1005 (Primary) ; HLX 22 (Primary) ; Docetaxel; Pertuzumab; Trastuzumab
Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
Focus Therapeutic Use
Sponsors Shanghai Henlius Biotech

25 Dec 2025 New trial record
09 Dec 2025 According to an Alligator Bioscience media release, applications for Phase 2/3 clinical trials of HLX22 in combination with HLX87 have been approved by China's NMPA.

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