Actively Recruiting
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
Led by Shanghai Henlius Biotech · Updated on 2026-03-20
706
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
CONDITIONS
Official Title
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and sign the informed consent form
- Aged 18 years or older, any gender
- Histologically confirmed advanced or metastatic HER2-positive breast cancer (IHC 3+ or IHC 2+ and ISH+)
- Hormone receptor status positive or negative as determined centrally
- No prior chemotherapy or HER2-targeted therapy for advanced/metastatic breast cancer (one line of endocrine therapy allowed)
- At least one measurable lesion by central imaging per RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1 within 7 days before starting study drugs
- Life expectancy of at least 12 weeks
- Adequate organ function
You will not qualify if you...
- History of a second cancer within 3 years before signing consent
- Prior use of doxorubicin exceeding 360 mg/m2 or equivalent
- Previous treatment with antibody-drug conjugates containing topoisomerase I inhibitors
- Uncontrolled or significant heart disease
- Cerebrovascular accident within 6 months before first study drug dose
- Interstitial lung disease, pneumonitis, or lung illness
- Active infection
- Spinal cord compression or symptomatic central nervous system metastases
- Unresolved toxicity from prior anti-cancer therapy above Grade 1 (except hair loss)
- Active tuberculosis
- Treatment with live attenuated vaccines within 30 days before first study drug dose
- Known severe allergy to protein preparations or study drug ingredients
- History of psychotropic drug abuse or drug addiction
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
M
Maoqing Fu, Dr
CONTACT
M
Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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