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

NCT06846437 | Recruiting Phase 3

• 1 other identifier: JSKN003-301
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) by BIRC

  Up to approximately 4 years

Secondary Outcomes (9)

• Progression-free survival (PFS) by investigator

  Up to approximately 4 years

• Overall Survival (OS)

  Up to approximately 4 years

• Objective Response Rate (ORR)

  Up to approximately 4 years

• Disease Control Rate (DCR)

  Up to approximately 4 years

• Duration of Response (DoR)

  Up to approximately 4 years

Study Arms (2)

JSKN003

EXPERIMENTAL

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

Drug: JSKN003

T-DM1

ACTIVE COMPARATOR

Received T-DM1 in accordance with the approved label.

Drug: Trastuzumab emtansine (T-DM1)

Interventions

JSKN003 DRUG

Administered intravenously according to protocol.

JSKN003

Trastuzumab emtansine (T-DM1) DRUG

Administered intravenously according to the approved label.

T-DM1

Eligibility Criteria

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

You may qualify if:

• \. Voluntarily agree to participate in the study and sign the informed consent.
• Age≥18 years old.
• Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology.
• 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.
• 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.
• Previously treated with taxanes.
• Had radiologic and/or pathologic progression or intolerance of the latest systemic anti-tumor therapy.
• At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• ECOG PS of 0 - 1.
• Patients with adequate organ and bone marrow functions.
• Expected survival ≥ 3 months.
• 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.

You may not qualify if:

• \. 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.
• History of any other malignant tumors within three years before randomization.
• With uncontrollable serous effusion within 14 days before randomization, which requires frequent drainage or medical intervention.
• Known contraindication to T-DM1or not suitable to receive JSKN003 or T-DM1 by investigator.
• 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).
• 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.
• Major organ surgery within 28 days before randomization.
• Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
• The cumulative amount of previous exposure to anthracyclines has reached the pre-specified dosage.
• History of LVEF \< 40% during prior anti-HER2 drug therapy or symptomatic congestive heart failure (CHF).
• Serious or uncontrolled cardiovascular disease.
• History of (non-infectious) interstitial lung disease/pneumonitis requiring therapy or grade ≥3 interstitial lung disease/ pneumonitis during previous anti-tumor treatments.
• Active infections requiring intravenous antibiotics, antivirals, or antifungals within 14 days before randomization.
• \. Active hepatitis B or hepatitis C.
• History of immunodeficiency or HIV antibody test positive at screening.

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Ado-Trastuzumab Emtansine

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhimin Shao, M.D. Organizational Affiliatio

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Zhimin Shao, M.D.

CONTACT

+86 18017312288; :szm@163.com

Study Design

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

Model Details: This is a randomized, controlled, open-label, multicenter, phase 3 clinical study. The primary endpoint of this study is PFS as assessed by BIRC. Participants with unrespectable locally advanced and/or metastatic HER2-positive breast cancer previously treated with trastuzumab and taxane are randomly assigned 1:1 stratified by hormone receptor status (positive or negative) and previous treatment lines (1L or ≥2L) to receive JSKN003 (experimental) or T-DM1 (active comparator).

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: February 26, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 24, 2025

Record last verified: 2025-02

Locations

CN (1)