A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
A Randomized, Controlled, Open-Label Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Triple-Negative Breast Cancer Who Have Failed at Least Two Lines of Prior Systemic Therapy
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
364 participants
Mar 17, 2026
INTERVENTIONAL
Conditions
Summary
Primary Endpoint of this Study: To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee \[BIRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST v1.1\]) between JSKN016 and Treatment of Physician's Choice (TPC) in participants with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC). To compare Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.
Eligibility
Plain Language Summary
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Interventions
Injection; 100 mg (4.0 mL)/vial. Dosage: 6 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle
Injection; 2 mL:1 mg (0.5 mg/mL). Dosage: 1.4 mg/m² administered via intravenous bolus on Day 1 and Day 8 of each 21-day cycle
Injection; 1 mL:10 mg (10 mg/mL). Dosage: 25 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
Tablet; 0.15 g and 0.5 g. Dosage: 1000-1250 mg/m² orally once daily on Days 1-14 of each 21-day cycle (14 days on/7 days off)
Injection; 0.2 g. Dosage: 1000 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
Injection; 180 mg/vial. Dosage: 10 mg/kg administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
Locations(1)
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NCT07533123