RecruitingPhase 1Phase 2NCT06942234

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

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


Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Enrollment

180 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing JSKN016, an antibody-drug conjugate (a drug that delivers chemotherapy directly into cancer cells), for patients with HER2-negative breast cancer that cannot be surgically removed or has spread. **You may be eligible if...** - You are aged 18–75 - You have confirmed HER2-negative breast cancer that is locally advanced or metastatic - If your cancer is hormone receptor-positive, it has progressed after standard hormone therapy - You have not had any prior systemic chemotherapy for advanced/metastatic breast cancer (prior hormone therapy is okay) - You have measurable disease outside the brain on scans - Your overall health and organ function meet the required thresholds **You may NOT be eligible if...** - You have active or unstable brain metastases - You have had prior chemotherapy for metastatic disease - You have severe heart problems (LVEF below 50%) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJSKN016

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.

DRUGCapecitabine

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.

DRUGPaclitaxel (albumin bound)

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.

DRUGEribulin

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.

DRUGPembrolizumab

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


Locations(1)

Fudan University Shanghai Cancer center

Shanghai, China

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NCT06942234