A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HLX43.
- Who it may be relevant to
- Registry conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Overview
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression 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)
Interventions
- Drug HLX43
HLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibodyratio (DAR) of 8.
Primary outcome measures
- ORR [Time frame: Up to 24WEEK]
- PFS [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Male/female who are at least 18 years of age and and no more than 75 years old on the day of signing the informed consent.
- With histologically confirmed diagnosis of HER2-negative, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
- Must have experienced disease progression after receiving at least one line of endocrine therapy for advanced or metastatic disease.
- Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- ECOG PS: 0-1.
- Expected survival ≥ 6 months.
- Had adequate organ function
Exclusion criteria
- Patients with other malignant tumors within 3 years before the randomization
- Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/pneumonitis
- Lung-specific intercurrent clinically significant illnesses
- Uncontrolled or significant cardiovascular disease or infection
- Prior adverse events leading to permanent discontinuation of immunotherapy; or prior immune-related pneumonia or immune-related myocarditis of grade ≥2.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07459738 · HLX43-BC201