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Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06942234•Jiangsu Alphamab Biopharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Capable of understanding and signing the informed consent form.
•2. Aged ≥18 and ≤75 years, regardless of sex.
•3. Histologically or cytologically confirmed inoperable locally advanced or metastatic HER2-negative breast cancer.
•4. Hormone receptor-positive participants with progression/intolerance after standard endocrine therapy, or unsuitable for it.
•5. Disease progression confirmed by radiological evidence post-systemic treatment.
•6. Available archived or newly obtained tumor tissue/biopsy.
•7. No prior systemic therapy for advanced disease, except for prior endocrine ± targeted therapy or CDK4/6 inhibitors.
•8. Measurable non-CNS lesion per RECIST 1.1.
•9. Expected survival ≥3 months.
•10. ECOG performance status of 0 or 1.
+7 more criteria

Exclusion Criteria

•1. CNS metastasis (except stable cases treated with radiation or surgery).
•2. Unstable spinal cord compression or untreated history.
•3. Recent live vaccine (except seasonal flu vaccines).
•4. Recent anti-tumor treatment within 28 days or 5 half-lives (whichever is shorter).
•5. Recent palliative therapy within 14 days.
•6. Major surgery within 28 days or planned during the study.
•7. Severe gastrointestinal issues or recent major GI bleeding.
•8. Uncontrolled pleural/peritoneal effusions or cachexia.
•9. Prior HER3/TROP2-targeted therapy or topoisomerase I inhibitors.
•10. Other malignancies within 5 years (except certain skin or localized cancers).
+8 more criteria

Locations (1)

Fudan University Shanghai Cancer center

Shanghai, China

Key Dates

Start Date

June 1, 2025

Primary Completion Date

June 30, 2027

Completion Date

December 31, 2027

Last Updated

September 17, 2025

Enrollment

180

ESTIMATED participants

Conditions

Inoperable Locally Advanced HER2-Negative Breast CancerMetastatic HER2-Negative Breast Cancer

Interventions

JSKN016

DRUG

Capecitabine

DRUG

Paclitaxel (albumin bound)

DRUG

Eribulin

DRUG

Pembrolizumab

DRUG

Contacts

Jian Zhang

CONTACT

+86-21-64175590 syner2000@126.com