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HER2-positive Recurrent or Metastatic Breast CancerPhase 2NCT07545044

A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer

A Phase 2 study testing JSKN003, Trastuzumab and Pertuzumab in people with HER2-positive Recurrent or Metastatic Breast Cancer, run by Shanghai JMT-Bio Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not previously received systemic therapy for advanced disease (participants who have undergone… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JSKN003, Trastuzumab and Pertuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
30 May 2026to 30 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1Voluntary participation in this study and signing of the informed consent form (ICF).
  • Age ≥ 18 years.
  • Histologically and/or cytologically confirmed recurrent or metastatic breast cancer.
  • HER2-positive tumor status confirmed by the central laboratory (Positive definition: IHC 3+, or IHC 2+ with positive ISH).
  • No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic disease. Participants who have received one prior endocrine therapy regimen are eligible. Participants who experienced recurrence more than 12 months after completing (neo)adjuvant HER2-targeted therapy may be considered for enrollment.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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  • Presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Adequate organ and bone marrow function (without transfusion or use of hematopoietic growth factors for correction within 14 days prior to testing):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Hemoglobin ≥ 90 g/L.
  • Hepatic function: Total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); alkaline phosphatase (ALP) ≤ 2.5 × ULN.
  • Renal function: Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula).
  • Coagulation function: International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. For participants receiving anticoagulant therapy, the investigator must deem both INR and APTT to be within a safe and effective therapeutic range.
  • Left ventricular ejection fraction (LVEF) > 50%.
  • Life expectancy ≥ 3 months.
  • For female participants of childbearing potential, a negative serum pregnancy test result must be obtained within 7 days prior to randomization. Participants of childbearing potential or those with partners of childbearing potential must agree to use reliable and effective methods of contraception during the study treatment period and for at least 7 months after the last dose of study treatment.

Who cannot join

  • Contraindications to trastuzumab, pertuzumab, and docetaxel, or deemed by the investigator as unsuitable for treatment with JSKN003.
  • Prior treatment with antibody-drug conjugates containing a topoisomerase I inhibitor (e.g., DS-8201, SHR-A1811, TQB-2102, etc.).
  • Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE 6.0 (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, peripheral neuropathy, or isolated laboratory abnormalities, which must have resolved to ≤ Grade 2).
  • During prior anti-HER2 therapy, left ventricular ejection fraction (LVEF) decreased to <50%, symptomatic congestive heart failure occurred, or toxicity leading to permanent treatment discontinuation was experienced.
  • Known hypersensitivity and/or contraindications to corticosteroids (including but not limited to active peptic ulcer disease, severe hypertension, severe hypokalemia, glaucoma, etc.).
  • Use of strong CYP3A4 inhibitors within 14 days prior to randomization.
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  • History of hypersensitivity to any component of the investigational drug(s) or any known excipient.
  • Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring corticosteroids or anticonvulsants to manage related symptoms. Participants are eligible if they have been clinically stable for >4 weeks after treatment for brain metastases without requiring corticosteroids or anticonvulsants and have recovered from acute toxicities of radiotherapy. Whole-brain radiotherapy or stereotactic radiosurgery must have been completed at least 2 weeks prior to study enrollment.
  • Active malignancy within 3 years prior to randomization, except for the breast cancer under investigation in this trial and any locally curable tumors that have undergone definitive treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, early-stage thyroid cancer, etc.).
  • Uncontrolled or significant cardiovascular or cerebrovascular diseases, including but not limited to:
  • New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction, or arrhythmia causing hemodynamic instability within 6 months prior to randomization;
  • Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);
  • History of clinically significant QT interval prolongation, or QTcF (calculated using Fridericia's formula) >480 ms during screening;
  • Arterial/venous thrombotic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).
  • History of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonitis requiring steroid treatment, current ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging during screening.
  • Clinically significant pulmonary-specific comorbidities, including but not limited to any underlying pulmonary disease within 3 months prior to study enrollment, (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, moderate to large pleural effusion, etc.).
  • Prior pneumonectomy.
  • Any documented autoimmune, connective tissue, or inflammatory disease (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).
  • History of immunodeficiency, such as congenital immunodeficiency disease, organ transplantation, etc..
  • Uncontrolled active infection or disease, including but not limited to:
  • Active HBV or HCV infection. Participants who are HBsAg positive and/or HCV antibody positive during screening must undergo HBV DNA and/or HCV RNA testing. Only participants with HBV DNA below the upper limit of normal and/or negative HCV RNA are eligible;
  • HIV infection or history of AIDS;
  • Known active tuberculosis;
  • Active syphilis. Participants with positive TP-Ab during screening must undergo TRUST or RPR testing; participants positive for both are excluded;
  • Other active infections or systemic use of anti-infective drugs for more than 1 week continuously within 28 days prior to randomization.
  • History of partial or complete intestinal obstruction, inflammatory bowel disease, chronic diarrhea, or gastrointestinal bleeding within 6 months prior to randomization.
  • Concurrent participation in another clinical study (except for non-interventional studies or the follow-up phase of an interventional study) or less than 4 weeks from the end of the previous clinical study (last dose) at the time of randomization.
  • Anti-tumor therapy including radiotherapy, targeted therapy, immunotherapy, and other investigational drugs within 28 days prior to randomization, or use of traditional Chinese medicine with anti-tumor indications within 14 days prior to randomization.
  • Uncontrolled serous cavity effusions (e.g., pleural effusion, ascites, pericardial effusion) requiring frequent drainage or medical intervention within 14 days prior to randomization, or requiring additional intervention within 2 weeks post-intervention (excluding cytological examination of effusion).
  • Major surgical procedures (e.g., abdominal, thoracic surgery; excluding minor procedures such as diagnostic puncture, infusion port placement, or biliary stent placement) within 28 days prior to randomization, or anticipated need for major surgery during the study period.
  • Women who are breastfeeding.
  • Any other condition that may interfere with the participant's ability to undergo study procedures, is not in the participant's best interest to participate, or may affect study outcomes: e.g., history of psychiatric disorders, drug or substance abuse, or any other clinically significant disease or condition.

About this study

Official title: A Randomized, Controlled, Open-Label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for Participants With HER2-Positive Recurrent or Metastatic Breast Cancer

This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not previously received systemic therapy for advanced disease (participants who have undergone one prior endocrine treatment regimen are eligible for enrollment). The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for participants with HER2-positive recurrent or metastatic breast cancer.

Read the detailed description

Approximately 60 participants will be enrolled in this study and randomly assigned in a 2:1 ratio to receive either JSKN003 (experimental group) or trastuzumab combined with pertuzumab and docetaxel (control group). Randomization will be stratified by hormone receptor status (both estrogen receptor and progesterone receptor negative vs. estrogen receptor and/or progesterone receptor positive).

Hormone receptor-positive participants in the experimental group may receive concomitant endocrine therapy after completing six cycles of treatment. Participants who are intolerant to JSKN003 may continue treatment with its parental antibody, KN026. Hormone receptor-positive participants in the control group may receive concomitant endocrine therapy after discontinuation of docetaxel treatment. All participants will receive the study treatment as planned until disease progression, unacceptable toxicity, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.

Being tested
JSKN003, Trastuzumab, Pertuzumab, Docetaxel
Keywords
breast cancer, HER2-positive, first-line treatment
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN003Drug

    6.3 mg/kg, IV, D1, Q3W

  • TrastuzumabDrug

    8mg/kg loading dose, then 6mg/kg, IV, D1, Q3W

  • PertuzumabDrug

    840mg loading dose, then 420mg, IV, D1, Q3W

  • DocetaxelDrug

    75 mg/m2, IV, D1, Q3W for minimum of 6 cycles or until intolerable toxicity[ym1.1][z1.2] or disease progression, whichever occurs first.

Study groups in NCT07545044
Study groupRoleWhat they receive
Experimental groupExperimentalJSKN003
Receives: Drug: JSKN003
Control groupActive comparatorTrastuzumab + Pertuzumab + Docetaxel
Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    ORR as Assessed by Investigator according to RECIST v1.1.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    PFS as Assessed by Investigator according to RECIST v1.1.

    Measured: Up to 2 years

  2. Disease Control Rate (DCR)

    DCR as Assessed by Investigator according to RECIST v1.1.

    Measured: Up to 2 years

  3. Duration of Response (DoR)

    DoR as Assessed by Investigator according to RECIST v1.1

    Measured: Up to 2 years

  4. Adverse Event (AE)

    Assess the incidence of all AE and serious adverse events (SAE).

    Measured: Up to 2 years

  5. Plasma concentrations of JSKN003, total antibodies, and free toxin

    Tests are conducted according to the protocol.

    Measured: Up to 2 years

  6. Incidence and titers of anti-drug antibodies (ADAs) to JSKN003, and incidence of neutralizing antibodies (NAbs, if applicable)

    Tests are conducted according to the protocol.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start30 May 2026 (estimated)
  3. Primary completion29 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07545044
Sponsor's protocol ID
JSKN003-008
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JSKN003, Trastuzumab and Pertuzumab in people with HER2-positive Recurrent or Metastatic Breast Cancer, run by Shanghai JMT-Bio Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07545044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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