NCT06846437招募中3 期
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
Shanghai JMT-Bio Inc.1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2025年2月18日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) by BIRC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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 -
- •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.
排除标准
- •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.
- •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.
- •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.
研究组 & 干预措施
JSKN003
Experimental
Received JSKN003 as a sterile intravenous (IV) solution at a dose of 6.3 mg/kg every 3 weeks (Q3W).
干预措施: JSKN003 (Drug)
T-DM1
Active Comparator
Received T-DM1 in accordance with the approved label.
干预措施: Trastuzumab emtansine (T-DM1) (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) by BIRC
时间窗: Up to approximately 4 years
次要结局
- Progression-free survival (PFS) by investigator(Up to approximately 4 years)
- Overall Survival (OS)(Up to approximately 4 years)
- Objective Response Rate (ORR)(Up to approximately 4 years)
- Disease Control Rate (DCR)(Up to approximately 4 years)
- Duration of Response (DoR)(Up to approximately 4 years)
- Incidence and severity of TEAE and SAE(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(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(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(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.)
研究者
研究点 (1)
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