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RECRUITING
NCT06832202
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

HLX22

HLX22 15mg/kg Q3W

DRUG

Trastuzumab Deruxtecan

Trastuzumab Deruxtecan 5.4mg/kg Q3W

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China