This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4/6 inhibitor-based endocrine therapy. Approximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.
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Incidence of dose-limiting toxicities (DLTs)
Timeframe: From first dose through the end of Cycle 1 (approximately 21 days)
Objective Response Rate (ORR)
Timeframe: From first dose through treatment discontinuation, assessed up to 12 months
Safety and tolerability (TEAEs, TRAEs, SAEs)
Timeframe: From first dose until 30 days after the last dose of study treatment.