A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer

Prior treatment

• 1\. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of \> 360 mg/m2 (or equivalent).
  • 3\. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.
  • 4\. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.
  • 6\. ILD/pneumonitis, or suspected ILD/pneumonitis or clinically significant lung-specific intercurrent illness .
  • 7\. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.
  • 9\. Residual toxicity from previous anti-tumor therapy that has not resolved to Grade ≤ 1 as per NCI-CTCAE V6.0 or baseline level (except for alopecia).
  • 10\. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs.
  • 12\. Known history of severe allergic reaction to macromolecular protein preparations, hypersensitivity to the ingredient of the investigational products, or severe hypersensitivity to any excipient of the study drugs.
  • 13\. Known history of abuse of psychotropic drugs or drug addiction. 14. Pregnant or lactating women.

• 1\. Have a full understanding of the study content, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria:
  • Advanced or metastatic breast cancer.
  • HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.
  • Positive or negative for hormone receptor HR (including estrogen receptor \[ER\] and progesterone receptor \[PgR\]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).
  • 5\. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.
  • 7\. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.
  • 8\. Life expectancy ≥ 12 weeks. 9. Adequate organ functions