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

Name: A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients — clinical trial record (NCT06832202)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 2

SponsorShanghai Henlius Biotech

Started2025-04-16

View on ClinicalTrials.gov ↗

Amendment history

2025-06-12

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-03-31→confirmed 2025-04-16

Study sitesdetails revised at 1 of 1 site

2025-02-12

Original filing

Shanghai Henlius Biotech

56 trials monitored

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Breast Cancer

5,180 trials monitored

See 256 trials at risk

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).

Trial Details

NCT Number	NCT06832202
Lead Sponsor	Shanghai Henlius Biotech
Conditions	HER2-low Hormone Receptor Positive Breast Cancer
Enrollment	50 participants
Start Date	2025-04-16
Primary Completion	2027-06-01 (estimated)
Study Completion	2029-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-15