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JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Summary
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.
Official title: A Multicenter, Open-Label, Phase Ib/II Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-01
Completion Date
2028-06
Last Updated
2026-01-13
Healthy Volunteers
No
Interventions
JSKN016 Q2W
4 mg/kg, intravenous infusion, every 2 weeks
JSKN016 Q3W
4 mg/kg, intravenous infusion, every 3 weeks
D-0502
200 mg, oral, once daily
Locations (1)
Fudan University Shanghai Cancer center
Shanghai, China