Phase II Study of SYS6023 Combined With KN026 for Treating Advanced or Metastatic Breast Cancer

What this Trial Is About

Researchers are conducting an open-label, multicenter Phase II clinical trial in adults with advanced breast cancer to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the drug SYS6023 in combination with other agents. The study focuses on patients with unresectable locally advanced or metastatic breast cancer who have progressed on or are intolerant to prior treatments. This trial is sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd. and aims to gather important information about these combination therapies to better understand their effects. Participants will receive SYS6023, a novel antibody-drug conjugate targeting HER3, combined with either HB1901 or KN026, an antibody targeting HER2. Both drugs are administered via intravenous infusion every three weeks. Treatment cycles continue until disease progression, intolerable toxicity, initiation of new anti-tumor therapies, withdrawal of consent, loss to follow-up, or death. The study includes a safety run-in period and a cohort expansion phase to assess dose levels and responses. Throughout the trial, participants will be closely monitored with assessments including tumor marker expression, plasma drug concentrations, and evaluations of disease control, response duration, progression-free survival, and overall survival. Safety is tracked by documenting adverse events and dose-limiting toxicities from baseline through up to three years after the last dose. Participants are expected to undergo regular laboratory tests and imaging to measure efficacy and safety outcomes during the treatment period and follow-up.

A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer