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Inoperable Locally Advanced HER2-Negative Breast CancerPhase 1/2NCT06942234

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

A Phase 1/2 study testing JSKN016, Capecitabine and Paclitaxel (albumin bound) in people with Inoperable Locally Advanced HER2-Negative Breast Cancer and Metastatic HER2-Negative Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
JSKN016, Capecitabine and Paclitaxel (albumin bound)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChina
Study dates
1 Jun 2025to 31 Dec 2027
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of understanding and signing the informed consent form.
  • Aged ≥18 and ≤75 years, regardless of sex.
  • Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer.
  • Hormone receptor-positive participants with progression/intolerance after standard endocrine therapy, or unsuitable for it.
  • Disease progression confirmed by radiological evidence post-systemic treatment.
  • Available archived or newly obtained tumor tissue/biopsy.
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  • No prior systemic therapy for advanced disease, except for prior endocrine ± targeted therapy or CDK4/6 inhibitors.
  • Measurable non-CNS lesion per RECIST 1.1.
  • Expected survival ≥3 months.
  • ECOG performance status of 0 or 1.
  • Contraceptive use agreement for fertile participants.
  • Adequate organ function within 7 days of enrollment:
  • Bone marrow: ANC ≥1.5 × 10⁹/L, Hemoglobin ≥90 g/L, Platelets ≥100 × 10⁹/L.
  • Liver: Bilirubin ≤1.5 × ULN, ALT/AST ≤3 × ULN.
  • Renal: Creatinine ≤1.5 × ULN or Ccr ≥60 mL/min.
  • Coagulation: INR/PT ≤1.5 × ULN, APTT ≤1.5 × ULN.
  • LVEF ≥50%.

Who cannot join

  • CNS metastasis (except stable cases treated with radiation or surgery).
  • Unstable spinal cord compression or untreated history.
  • Recent live vaccine (except seasonal flu vaccines).
  • Recent anti-tumor treatment within 28 days or 5 half-lives (whichever is shorter).
  • Recent palliative therapy within 14 days.
  • Major surgery within 28 days or planned during the study.
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  • Severe gastrointestinal issues or recent major GI bleeding.
  • Uncontrolled pleural/peritoneal effusions or cachexia.
  • Prior HER3/TROP2-targeted therapy or topoisomerase I inhibitors.
  • Other malignancies within 5 years (except certain skin or localized cancers).
  • Current interstitial lung disease or uncontrolled infections.
  • Severe hypercalcemia or uncontrolled cancer-related pain.
  • Autoimmune diseases, unless stable with treatment.
  • Uncontrolled comorbidities (e.g., active infections, cardiovascular issues).
  • Toxicities from previous treatments not resolved to CTCAE ≤1.
  • Recent steroid use or need for systemic immunosuppressive therapy.
  • Allergy to study drug components.
  • Pregnancy or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jian Zhang contact

+86-21-64175590

syner2000@126.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer center

    Shanghai

    Jian Zhang, +86 18017312990

    Recruiting

Other trials in China

About this study

Official title: The Multicenter, Open-label, Single-arm, Multi-cohort Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of JSKN016 in Combination Therapy in Chinese Participants With Inoperable Locally Advanced or Metastatic HER2-negative Breast Cancer

This study aims to evaluate the safety and effectiveness of JSKN016 in combination with different treatments for patients with HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. The study includes four groups of patients based on treatment history and tumor characteristics. Each group will receive JSKN016 with chemotherapy or immunotherapy. The goal is to find out how well the treatment works and how safe it is.

Read the detailed description

This clinical study investigates the safety and efficacy of JSKN016 combined with various therapies for patients with advanced, inoperable, or metastatic HER2-negative breast cancer. The study includes four groups with different treatment regimens, targeting HR+HER2-negative breast cancer and triple-negative breast cancer (TNBC) with varying prior treatments. Participants will receive JSKN016 in combination with paclitaxel, capecitabine, eribulin, or pembrolizumab. The primary endpoint is the objective response rate (ORR) based on RECIST 1.1 criteria. The secondary endpoints include efficacy, safet, and other related outcomes.

Being tested
JSKN016, Capecitabine, Paclitaxel (albumin bound), Eribulin, Pembrolizumab

What participants receive

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

  • JSKN016Drug

    JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.

  • CapecitabineDrug

    The drug is administered orally at a dose of 1000mg/m², twice daily for two weeks, followed by a one-week break. Treatment cycles repeat every three weeks.

  • Paclitaxel (albumin bound)Drug

    The drug is administered intravenously at a dose of 125mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.

  • EribulinDrug

    The drug is administered intravenously at a dose of 1.4mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.

  • PembrolizumabDrug

    The drug is administered intravenously at a fixed dose of 200mg, with infusions on Day 1 of each 3-week treatment cycle.

Study groups in NCT06942234
Study groupRoleWhat they receive
Cohort 1: JSKN016+PaclitaxelExperimentalJSKN016 (5mg/kg IV Q3W D1) + nab-paclitaxel (125mg/m² IV Q3W D1, D8)
Receives: Drug: JSKN016; Drug: Paclitaxel (albumin bound)
Cohort 2: JSKN016+CapecitabineExperimentalJSKN016 (5mg/kg IV Q3W D1) + capecitabine (1000mg/m² PO BID Q3W D1-14)
Receives: Drug: JSKN016; Drug: Capecitabine
Cohort 3: JSKN016+EribulinExperimentalJSKN016 (5mg/kg IV Q3W D1) + eribulin (1.4mg/m² IV Q3W D1, D8)
Receives: Drug: JSKN016; Drug: Eribulin
Cohort 4: JSKN016+Pembrolizumab/ToripalimabExperimentalJSKN016 (5mg/kg IV Q3W D1) + pembrolizumab (200mg IV Q3W D1) or toripalimab (240mg IV Q3W D1).
Receives: Drug: JSKN016; Drug: Pembrolizumab

What is being measured

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

  1. Objetctive Response Rate (ORR)

    The proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), as assessed by investigators according to RECIST v1.1 criteria.

    Measured: From baseline until disease progression, death, or end of treatment, whichever occurs first (up to approximately 24 months)

Secondary outcomes (5)

  1. Duration of Response (DoR)

    The time from the first documentation of CR or PR to the first documentation of disease progression or death from any cause, whichever occurs first, as assessed by investigators per RECIST v1.1.

    Measured: From first documented response to progression or death (up to approximately 24 months)

  2. Disease Control Rate (DCR)

    The proportion of participants who achieve a best overall response of CR, PR, or stable disease (SD), as assessed by investigators using RECIST v1.1 criteria.

    Measured: From baseline to disease progression or end of treatment (up to approximately 24 months)

  3. Progression-Free Survival (PFS)

    Time from the date of first dose of study drug to the first documentation of disease progression or death from any cause, whichever occurs first, based on investigator assessment using RECIST v1.1.

    Measured: From first dose until disease progression or death (up to approximately 24 months)

  4. Overall Survival (OS)

    Time from the date of first dose of study drug to death from any cause.

    Measured: From first dose to death (up to approximately 36 months)

  5. Frequency and Severity of Adverse Events (AEs)

    Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), coded using MedDRA and graded per NCI-CTCAE v5.0.

    Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 30 months)

Timeline

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

  1. First posted24 Apr 2025
  2. Study start1 Jun 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06942234
Sponsor's protocol ID
JSKN016-202
Status last verified
Sep 2025
First submitted
10 Apr 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JSKN016, Capecitabine and Paclitaxel (albumin bound) in people with Inoperable Locally Advanced HER2-Negative Breast Cancer and Metastatic HER2-Negative Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd 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 17 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 17 Sep 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Jian Zhang (+86-21-64175590, syner2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objetctive Response Rate (ORR) (time frame: From baseline until disease progression, death, or end of treatment, whichever occurs first (up to approximately 24 months)). 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 NCT06942234.

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 17 Sep 2025.

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