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

Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study ID
NCT07533123
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JSKN016 Injection — DRUG
    Injection; 100 mg (4.0 mL)/vial. Dosage: 6 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle
  • Eribulin Mcsilate Injection — DRUG
    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
  • Vinorelbine Tartrate Injection — DRUG
    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
  • Capecitabine Tablets — DRUG
    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)
  • Gemcitabine Hydrochloride for Injection — DRUG
    Injection; 0.2 g. Dosage: 1000 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
  • Sacituzumab Govitecan for Injection — DRUG
    Injection; 180 mg/vial. Dosage: 10 mg/kg administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
Apr 2026
Primary completion
Mar 17, 2029
Completion
Mar 17, 2030

Study Design

Enrollment
364 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JSKN016
  • Active Comparator: Treatment of Physician's Choice

Primary Outcome Measure

PFS (Progression-Free Survival) [ Time Frame: From randomization to date of first documented progression or date of death from any cause. Up to approximately 3 years after the first enrollment. ]

Central Contacts

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