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

NCT06942234 | Recruiting Phase 1

• 1 other identifier: JSKN016-202
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inoperable Locally Advanced HER2-Negative Breast Cancer; Metastatic HER2-Negative Breast Cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Duration of Response (DoR)

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

• Disease Control Rate (DCR)

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

• Progression-Free Survival (PFS)

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

• Overall Survival (OS)

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

• Frequency and Severity of Adverse Events (AEs)

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

Study Arms (4)

Cohort 1: JSKN016+Paclitaxel

EXPERIMENTAL

JSKN016 (5mg/kg IV Q3W D1) + nab-paclitaxel (125mg/m² IV Q3W D1, D8)

Drug: JSKN016; Drug: Paclitaxel (albumin bound)

Cohort 2: JSKN016+Capecitabine

EXPERIMENTAL

JSKN016 (5mg/kg IV Q3W D1) + capecitabine (1000mg/m² PO BID Q3W D1-14)

Drug: JSKN016; Drug: Capecitabine

Cohort 3: JSKN016+Eribulin

EXPERIMENTAL

JSKN016 (5mg/kg IV Q3W D1) + eribulin (1.4mg/m² IV Q3W D1, D8)

Drug: JSKN016; Drug: Eribulin

Cohort 4: JSKN016+Pembrolizumab/Toripalimab

EXPERIMENTAL

JSKN016 (5mg/kg IV Q3W D1) + pembrolizumab (200mg IV Q3W D1) or toripalimab (240mg IV Q3W D1).

Drug: JSKN016; Drug: Pembrolizumab

Interventions

JSKN016 DRUG

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.

Cohort 1: JSKN016+Paclitaxel; Cohort 2: JSKN016+Capecitabine; Cohort 3: JSKN016+Eribulin; Cohort 4: JSKN016+Pembrolizumab/Toripalimab

Capecitabine DRUG

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.

Cohort 2: JSKN016+Capecitabine

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.

Cohort 1: JSKN016+Paclitaxel

Eribulin DRUG

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.

Cohort 3: JSKN016+Eribulin

Pembrolizumab DRUG

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

Cohort 4: JSKN016+Pembrolizumab/Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; Taxes; eribulin; pembrolizumab

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Economics; Health Care Economics and Organizations

Central Study Contacts

Jian Zhang

CONTACT

+86-21-64175590; syner2000@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)