JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer

NCT ID: NCT06846437

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2028-12-31

Brief Summary

This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.

Detailed Description

This is a randomized, controlled, open-label, multicenter, phase 3 clinical study to compare the efficacy and safety of JSKN003 versus T-DM1 in unresectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane. Participants will be treated with JSKN003 at 6.3 mg/kg or trastuzumab emtansine at 3.6 mg/kg every 3 weeks (Q3W). Participants will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.

Conditions

Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JSKN003

Received JSKN003 as a sterile intravenous (IV) solution at a dose of 6.3 mg/kg every 3 weeks (Q3W).

Group Type: EXPERIMENTAL

JSKN003

Intervention Type: DRUG

Administered intravenously according to protocol.

T-DM1

Received T-DM1 in accordance with the approved label.

Group Type: ACTIVE_COMPARATOR

Trastuzumab emtansine (T-DM1)

Intervention Type: DRUG

Administered intravenously according to the approved label.

Interventions

JSKN003

Administered intravenously according to protocol.

Intervention Type: DRUG

Trastuzumab emtansine (T-DM1)

Administered intravenously according to the approved label.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Voluntarily agree to participate in the study and sign the informed consent.
• 2.Age≥18 years old.
• 3.Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology.
• 4.Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive) by the pathology department of participating study center.
• 5.Have received treatment regimen including trastuzumab (allowed marketed trastuzumab biosimilars) or inetetamab with radiologic or pathologic progression/ relapse during the advanced stage, during neoadjuvant or adjuvant therapy, or within 12 months after treatment.
• 6.Previously treated with taxanes.
• 7.Had radiologic and/or pathologic progression or intolerance of the latest systemic anti-tumor therapy.
• 8.At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• 9.ECOG PS of 0 - 1.
• 10.Patients with adequate organ and bone marrow functions.
• 11.Expected survival ≥ 3 months.
• 12.Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose of JSKN003 or T-DM1.

Exclusion Criteria

• 1. Have previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors or medenosin derivative 1 (DM1) or have relapsed after receiving such therapy during or within 12 months after the adjuvant/neo-adjuvant setting or in the advanced stage.
• 2.History of any other malignant tumors within three years before randomization.
• 3.With uncontrollable serous effusion within 14 days before randomization, which requires frequent drainage or medical intervention.
• 4.Known contraindication to T-DM1or not suitable to receive JSKN003 or T-DM1 by investigator.
• 5.Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ Grade 1 (refer to NCI CTCAE 5.0) or baseline (excluding grade 2 alopecia, hyperpigmentation, simple laboratory test abnormalities, and other toxicity for a non-safety risk by investigators).
• 6.Received immunotherapy, macromolecular targeted therapy or other anti-tumor biological therapy within 4 weeks before randomization, or received palliative radiotherapy, endocrine therapy, cytotoxic drug chemotherapy and small molecular targeted drug therapy within 2 weeks before randomization, or received traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before randomization.
• 7.Major organ surgery within 28 days before randomization.
• 8.Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
• 9.The cumulative amount of previous exposure to anthracyclines has reached the pre-specified dosage.
• 10.History of LVEF < 40% during prior anti-HER2 drug therapy or symptomatic congestive heart failure (CHF).
• 11.Serious or uncontrolled cardiovascular disease.
• 12.History of (non-infectious) interstitial lung disease/pneumonitis requiring therapy or grade ≥3 interstitial lung disease/ pneumonitis during previous anti-tumor treatments.
• 13.Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization.
• 14. Active hepatitis B or hepatitis C.
• 15.History of immunodeficiency or HIV antibody test positive at screening.
• 16.Received a potent inhibitor of CYP3A4 within 14 days prior to randomization or during study treatment.
• 17.Pregnant or nursing females;
• 18.Other reasons enrolled in this clinical trial as considered unsuitable by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai JMT-Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhimin Shao, M.D. Organizational Affiliatio

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Zhimin Shao, M.D.

Role: CONTACT

:szm@163.com

+86 18017312288

Facility Contacts

Zhimin Shao, M.D.

Role: primary

szm@163.com

+86 18017312288

Other Identifiers

JSKN003-301

Identifier Type: -

Identifier Source: org_study_id