NCT06492005招募中2 期
A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
- •Male or female subjects aged 18 to 75 years (including 18 and 75 years).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy.
- •Subjects who have failed standard treatment or naive to systemic antitumor therapy in advanced setting.
- •Subjects must submit tumor tissues for test.
- •Life expectancy of ≥ 12 weeks.
- •Subjects must have measurable disease according to RECIST (version 1.1).
- •Adequate organ functions.
- •Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
- •Subjects are willing to follow study procedures
排除标准
- •Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions
- •Preexisting peripheral neuropathy Grade ≥
- •Hemoglobin A1C (HbA1c) ≥ 8%.
- •Has ocular conditions that may increase the risk of corneal epithelium damage.
- •History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases.
- •Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug (Cohort A). Received immune checkpoint inhibitor or systemic immunosuppressive therapy was administered within 14 days prior to the first study (Cohort B and C). traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC with MMAE payload, any P-glycoprotein (P-gp) inducers/inhibitors or strong CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug, major surgery within 28 days prior to first dose of study drug or any live vaccines within 28 days before first dose of study drug or during the study..
- •History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- •Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
- •Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug
- •Active autoimmune disease requiring systemic treatment within 2 years before the subject's first study medication.
- •History of another malignancy within 3 years before the first dose of study drug.
- •Not suitable to receive study treatment for other conditions as per investigator.
研究组 & 干预措施
Treatment Cohort A:9MW2821
Experimental
Drug：9MW2821
干预措施: 9MW2821 (Drug)
Treatment Cohort B:9MW2821+PD-1 inhibitior
Experimental
Drug: 9MW2821,PD-1 inhibitior
干预措施: 9MW2821 (Drug)
Treatment Cohort B:9MW2821+PD-1 inhibitior
Experimental
Drug: 9MW2821,PD-1 inhibitior
干预措施: PD-1 inhibitior (Drug)
Treatment Cohort C:9MW2821 ±PD-1 inhibitior
Experimental
Drug: 9MW2821,PD-1 inhibitior
干预措施: 9MW2821 (Drug)
Treatment Cohort C:9MW2821 ±PD-1 inhibitior
Experimental
Drug: 9MW2821,PD-1 inhibitior
干预措施: PD-1 inhibitior (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to 24 months
ORR
次要结局
- Overall Survival(Up to 24 months)
- Duration of Response(Up to 24 months)
- Time to Response(Up to 24 months)
- Disease Control Rate(Up to 24 months)
- Progression Free Survival(Up to 24 months)
- Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)(24 months)
- Incidence of Anti-Drug Antibody (ADA)(Up to 24 months)
研究者
研究点 (1)
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