drugset / Trial / NCT06832202

A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients

NCT06832202

Phase 2 Recruiting 50 enrolled Shanghai Henlius Biotech
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Timeline

Start
2025-04-16
Primary completion
2027-06-01
Completion
2029-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX22 Monoclonal antibody 15 mg/kg
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg