Actively Recruiting
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
Led by Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Updated on 2026-04-16
364
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of JSKN016 compared to the Treatment of Physician's Choice (TPC) in patients with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC) who have not responded to at least two prior systemic chemotherapy treatments. The study focuses on measuring progression-free survival (PFS) and overall survival (OS) to understand how well JSKN016 works against this aggressive form of breast cancer. Participants will be randomly assigned to receive either JSKN016 or one of several physician-chosen treatments, including eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan. JSKN016 is given as an intravenous infusion at a dose of 6 mg/kg on Day 1 of each 21-day cycle. Comparator drugs are administered according to their individual schedules within the same 21-day cycle framework. The trial is open-label, meaning both participants and doctors know which treatment is given. Throughout the study, participants will be monitored for tumor progression using standard response criteria and followed for survival outcomes for up to approximately three years after enrollment. Researchers will assess tumor response through imaging and other evaluations, track safety, and collect tumor tissue samples. Participants must be between 18 and 75 years old with adequate organ function and measurable disease. The trial duration and assessments are designed to provide comprehensive data on treatment impact and participant well-being.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the Informed Consent Form (ICF).
- Age 18 years or older and 75 years or younger at the time of signing the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Confirmed diagnosis of triple-negative breast cancer based on recent pathology.
- Failure of at least two prior lines of systemic chemotherapy.
- At least one measurable extracranial lesion per RECIST v1.1.
- Agree to provide a tumor tissue sample.
- Adequate organ and bone marrow function.
- Recovery from prior treatment-related toxicities to Grade 1 or lower.
- Suitable to receive eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan.
- Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to randomization and agree to use contraception during the trial.
You will not qualify if you...
- Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate, except TROP2-targeted ADCs.
- Diagnosis of another malignancy within 5 years prior to randomization, excluding certain skin cancers and in situ carcinomas.
- Presence of cerebrovascular or cardiovascular diseases or related risk factors.
- Inadequate washout period from prior therapies.
- Active central nervous system metastases without prior local treatment or involvement of brainstem, meninges, spinal cord, or carcinomatous meningitis.
- Severe or uncontrolled concomitant diseases affecting safety or compliance.
- Tumor invasion of adjacent vital organs or risk of fistulas.
- Active hepatitis B or C infections.
- Positive test for HIV or history of AIDS; active syphilis or tuberculosis infection.
- History of allogeneic bone marrow or organ transplantation.
- History of significant eye diseases.
- History of interstitial lung disease or pneumonitis requiring steroid treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive their assigned drug treatment, which may include JSKN016 or one of several physician's choice drugs. Treatments are given in cycles with intravenous infusions or oral medications on specific days within each 21-day cycle.
Visits on Day 1 and Day 8 of each 21-day cycle
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510289
Actively Recruiting
Research Team
Y
Yuan Huang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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