drugset
drugset / Trial / NCT07824869

A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients

NCT07824869 ↗

Phase 2 Not yet recruiting 90 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously treated with HER2 ADC. Eligible participants will be treated with the study drug until the loss of clinical benefit, intolerable toxicity, initiation of new anti-tumor therapy, voluntary withdrawal from the study by the patient, loss to follow-up, death, or when the investigator determines that the patient should be withdrawn from the study (whichever occurs first).

Timeline

Start
2026-10-31
Primary completion
2028-03-31
Completion
2029-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX22 Monoclonal antibody 15 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Docetaxel Small molecule 100 mg/m2 Intravenous
Background Eribulin Small molecule 1.4 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Paclitaxel Small molecule 90 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Vinorelbine Small molecule 25 mg/m2 Intravenous
Background Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications

HER2 positive breast carcinoma