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

Recruiting Phase 3 Interventional Study
Triple Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
364 (estimated)
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
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About This Trial
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 Over…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Voluntarily sign the Informed Consent Form (ICF). * Age ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥ 3 months. * Histologically and/or cytologically confi…
Contacts

Yuan Huang

0512-62850800

yuanhuang@alphamabonc.com

CONTACT