Actively Recruiting
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
Led by Shanghai Henlius Biotech · Updated on 2025-06-15
50
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically confirmed HER2-low, hormone receptor positive locally advanced or metastatic breast cancer
- HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) on metastatic tumor, never previously HER2-positive, with documented HR+ disease in metastatic setting
- Measurable disease per RECIST v1.1, excluding bone-only metastases
- ECOG performance status 0-1
- Expected survival of at least 6 months
- Adequate organ function
You will not qualify if you...
- Other malignant tumors within 3 years before randomization
- Previous treatment with any HER2-targeted therapy
- Uncontrolled or significant cardiovascular disease or infection
- Lung-specific clinically significant illnesses
- Prior or current interstitial lung disease (ILD)/pneumonitis requiring steroids or suspected ILD/pneumonitis
- Spinal cord compression or clinically active central nervous system metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
Y
Yun Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here