A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression
• Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
• Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system \[Version 8\]) who are not candidates for curative surgery or radiotherapy.
• Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.
• Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.
• Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.
• Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Have Adequate organ and bone marrow function within 7 days prior to the first dose.
• Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.
• Have a expected survival ≥ 3 months.
⁃ Have ability and willingness to comply with protocol-specified visits and procedures.