Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.

The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC).

NCT Number	NCT07487519
Lead Sponsor	Shanghai Henlius Biotech
Conditions	Breast Cancer (Triple Negative Breast Cancer (TNBC))
Enrollment	180 participants
Start Date	2026-04-25
Primary Completion	2027-05-15 (estimated)
Study Completion	2028-05-22 (estimated)
Updated on ClinicalTrials.gov	2026-03-23