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)
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.
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
Parallel
HLX43
DrugHLX43 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.
ORR
Objective response rate (ORR) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1
PFS
Progression-Free Survival (PFS) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1
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This trial is not recruiting at the moment. You can still explore other options:
