Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
Sponsor: Shanghai Henlius Biotech
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).
Official title: A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-04-16
Completion Date
2029-12-01
Last Updated
2025-06-15
Healthy Volunteers
No
Interventions
HLX22
HLX22 15mg/kg Q3W
Trastuzumab Deruxtecan
Trastuzumab Deruxtecan 5.4mg/kg Q3W
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China