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

April 14, 2026 updated by: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

364

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510289
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 confirmed diagnosis of Triple-Negative Breast Cancer (TNBC) based on pathology reports from the most recent biopsy or other pathological specimens.
  • Failure of at least 2 prior lines of systemic chemotherapy.
  • At least one measurable extracranial lesion per Response Evaluation Criteria in Solid -Tumors (RECIST) v1.1.
  • Agree to provide a tumor tissue specimen.
  • Adequate organ and bone marrow function.
  • Recovery from prior treatment-related toxicities to ≤ Grade 1 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or as specified in the protocol for eligibility.
  • Assessed by the investigator as suitable to receive one of the following: eribulin, capecitabine, gemcitabine, vinorelbine, or sacituzumab govitecan.
  • Female participants of childbearing potential must have a negative serum/urine pregnancy test within 7 days prior to randomization and agree to contraception during the trial.

Exclusion Criteria:

  • Prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC), with the exception of TROP2-targeted ADCs.
  • Diagnosis of another malignancy within 5 years prior to randomization, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma, cervical carcinoma in situ, and other carcinomas in situ.
  • Presence of cerebrovascular or cardiovascular diseases or risk factors.
  • Inadequate washout from prior therapies prior to randomization.
  • Presence of active central nervous system (CNS) metastases without prior local treatment; presence of metastases or compression of the brainstem, meninges, or spinal cord; or history of carcinomatous meningitis.
  • Presence of severe or uncontrolled concomitant diseases that may affect safety or compliance.
  • Tumor invasion of adjacent vital organs or blood vessels (such as the heart, esophagus, superior vena cava, etc.) or risk of developing an esophagotracheal fistula or esophagopleural fistula.
  • Active hepatitis B; active hepatitis C.
  • Positive test for human immunodeficiency virus (HIV) or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; known active tuberculosis infection.
  • History of allogeneic bone marrow or organ transplantation.
  • History of significant ophthalmic diseases.
  • History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment of Physician's Choice
Drug: Eribulin Mcsilate Injection
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
Drug: Vinorelbine Tartrate Injection
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
Drug: Capecitabine Tablets
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)
Drug: Gemcitabine Hydrochloride for Injection
Injection; 0.2 g. Dosage: 1000 mg/m² administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
Drug: Sacituzumab Govitecan for Injection
Injection; 180 mg/vial. Dosage: 10 mg/kg administered via intravenous infusion on Day 1 and Day 8 of each 21-day cycle
Experimental: JSKN016
Drug: JSKN016 Injection
Injection; 100 mg (4.0 mL)/vial. Dosage: 6 mg/kg administered via intravenous infusion on Day 1 of each 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
PFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 as assessed by BIRC, or death from any cause, whichever occurs first.
From randomization to date of first documented progression or date of death from any cause. Up to approximately 3 years after the first enrollment.
OS (Overall Survival)
Time Frame: From randomization to date of death from any cause.Up to approximately 3 years after the first enrollment.
OS is defined as the time from randomization to death from any cause.
From randomization to date of death from any cause.Up to approximately 3 years after the first enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 17, 2026

Primary Completion (Estimated)

March 17, 2029

Study Completion (Estimated)

March 17, 2030

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSKN016-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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