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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

ConditionTriple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Alphamab Biopharmaceuticals Co., Ltd

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 Overall Survival (OS) between JSKN016 and TPC in the treatment of unresectable locally advanced, recurrent, or metastatic TNBC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

364 Participants
are divided into 2 treatment groups
Group A: JSKN016Experimental treatment 1 intervention
Group B: Treatment of Physician's ChoiceActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

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.

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.
2

OS (Overall Survival)

OS is defined as the time from randomization to death from any cause.

Time frame
From randomization to date of death from any cause.Up to approximately 3 years after the first enrollment.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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