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

NCT07533123 | Recruiting Phase 3 DMC

• 1 other identifier: JSKN016-301
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• PFS (Progression-Free Survival)

  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)

  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.

Study Arms (2)

JSKN016

EXPERIMENTAL

Drug: JSKN016 Injection

Treatment of Physician's Choice

ACTIVE COMPARATOR

Drug: Eribulin Mcsilate Injection; Drug: Vinorelbine Tartrate Injection; Drug: Capecitabine Tablets; Drug: Gemcitabine Hydrochloride for Injection; Drug: Sacituzumab Govitecan for Injection

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

JSKN016

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

Treatment of Physician's Choice

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

Treatment of Physician's Choice

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)

Treatment of Physician's Choice

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

Treatment of Physician's Choice

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

Treatment of Physician's Choice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510289, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Vinorelbine; Capecitabine; Gemcitabine; Injections; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yuan Huang

CONTACT

0512-62850800; yuanhuang@alphamabonc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 16, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): March 17, 2029
• Study Completion (Estimated): March 17, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)