RecruitingPhase 2NCT06832202

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

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


Sponsor

Shanghai Henlius Biotech

Enrollment

50 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing a combination of two targeted therapies — HLX22 and trastuzumab deruxtecan — in patients with breast cancer that has a low level of the HER2 protein (called HER2-low) and is also hormone receptor-positive. The cancer has either spread to other parts of the body or cannot be surgically removed. **You may be eligible if...** - You are at least 18 years old - You have been diagnosed with HER2-low, hormone receptor-positive advanced or metastatic breast cancer - HER2-low means your cancer tests show low but not negative HER2 levels (specific test score required) - You have measurable tumor on imaging (not only bone metastases) - Your overall health status is good (ECOG 0–1) - Your expected survival is at least 6 months **You may NOT be eligible if...** - You have had another cancer diagnosis in the past 3 years - You have previously received certain HER2-targeted treatments - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX22

HLX22 15mg/kg Q3W

DRUGTrastuzumab Deruxtecan

Trastuzumab Deruxtecan 5.4mg/kg Q3W


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06832202


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