Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer ParticipantsPhase 3NCT06846437
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
A Phase 3 study testing JSKN003 and Trastuzumab emtansine (T-DM1) in people with Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
- What is being tested?
- JSKN003 and Trastuzumab emtansine (T-DM1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 31 Dec 2028
- Phase
- Phase 3
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Zhimin Shao, M.D., +86 18017312288, szm@163.com
About this study
Official title: A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer Subjects
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.
Read the 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.
- Being tested
- JSKN003, Trastuzumab emtansine (T-DM1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSKN003Drug
Administered intravenously according to protocol.
Trastuzumab emtansine (T-DM1)Drug
Administered intravenously according to the approved label.
| Study group | Role | What they receive |
|---|---|---|
| JSKN003 | Experimental | Received JSKN003 as a sterile intravenous (IV) solution at a dose of 6.3 mg/kg every 3 weeks (Q3W). Receives: Drug: JSKN003 |
| T-DM1 | Active comparator | Received T-DM1 in accordance with the approved label. Receives: Drug: Trastuzumab emtansine (T-DM1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) by BIRC
Measured: Up to approximately 4 years
Secondary outcomes (9)
Progression-free survival (PFS) by investigator
Measured: Up to approximately 4 years
Overall Survival (OS)
Measured: Up to approximately 4 years
Objective Response Rate (ORR)
Measured: Up to approximately 4 years
Disease Control Rate (DCR)
Measured: Up to approximately 4 years
Duration of Response (DoR)
Measured: Up to approximately 4 years
Incidence and severity of TEAE and SAE
Measured: From the signing of informed consent to the safety follow-up period or before starting a new anti-tumor therapy, whichever occurs first, assessed up to approximately 4 years.
Cmax of JSKN003
Measured: Cycles 1, 2, 3, 4 (each cycle is 3 weeks), and every 4 cycles starting from Cycle 4; End of treatment and safety follow-up visit, for approximately 4 years
AUC of JSKN003
Measured: Cycles 1, 2, 3, 4 (each cycle is 3 weeks), and every 4 cycles starting from Cycle 4; End of treatment and safety follow-up visit, for approximately 4 years
Incidence of anti-drug antibodies (ADA) to JSKN003
Measured: Pre-dose for Cycles 1, 2, 3, 4 (each cycle is 3 weeks), and every 4 cycles starting from Cycle 4; End of treatment and safety follow-up visit, for approximately 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start18 Feb 2025
- Primary completion13 Oct 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer ParticipantsStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhimin Shao, M.D. Organizational Affiliatio, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846437
- Sponsor's protocol ID
- JSKN003-301
- Status last verified
- Feb 2025
- First submitted
- 6 Jan 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer Subjects
- ClinicalTrials.gov ID
- NCT06846437
- Acronym / sponsor ID
- JSKN003-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| JSKN003 | Experimental | Drug: JSKN003Received JSKN003 as a sterile intravenous (IV) solution at a dose of 6.3 mg/kg every 3 weeks (Q3W). |
| T-DM1 | Active comparator | Drug: Trastuzumab emtansine (T-DM1)Received T-DM1 in accordance with the approved label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JSKN003Administered intravenously according to protocol. | Drug | JSKN003 |
| Trastuzumab emtansine (T-DM1)Administered intravenously according to the approved label. | Drug | T-DM1 |
Primary outcome
Progression-Free Survival (PFS) by BIRC
Time frame: Up to approximately 4 years
9 secondary outcomes
Progression-free survival (PFS) by investigator
Time frame: Up to approximately 4 years
Overall Survival (OS)
Time frame: Up to approximately 4 years
Objective Response Rate (ORR)
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
Time frame: Up to approximately 4 years
Duration of Response (DoR)
Time frame: Up to approximately 4 years
Incidence and severity of TEAE and SAE
Time frame: From the signing of informed consent to the safety follow-up period or before starting a new anti-tumor therapy, whichever occurs first, assessed up to approximately 4 years.
Cmax of JSKN003
Time frame: Cycles 1, 2, 3, 4 (each cycle is 3 weeks), and every 4 cycles starting from Cycle 4; End of treatment and safety follow-up visit, for approximately 4 years
AUC of JSKN003
Time frame: Cycles 1, 2, 3, 4 (each cycle is 3 weeks), and every 4 cycles starting from Cycle 4; End of treatment and safety follow-up visit, for approximately 4 years
Incidence of anti-drug antibodies (ADA) to JSKN003
Time frame: Pre-dose for Cycles 1, 2, 3, 4 (each cycle is 3 weeks), and every 4 cycles starting from Cycle 4; End of treatment and safety follow-up visit, for approximately 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhimin Shao, M.D. Organizational Affiliatio principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JSKN003 and Trastuzumab emtansine (T-DM1) in people with Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants, run by Shanghai JMT-Bio Inc. at 1 site in China.
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 12 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) by BIRC (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2025.