NCT07556848尚未招募3 期
A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Have Previously Received Taxane-based Chemotherapy With or Without Immunotherapy and an Antibody-drug Conjugate With a Topoisomerase Inhibitor Payload
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload
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).
- •Histopathological diagnosed triple-negative breast cancer.
- •Patient has previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.
- •Suitable for one of active comparator chemotherapy assessed by investigator.
- •An archival tumor tissue sample or a fresh tissue sample should be provided.
- •Life expectancy of ≥ 12 weeks.
- •Subjects must have measurable disease according to RECIST (version 1.1).
- •Adequate organ functions.
- •Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
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 or symptoms that may increase the risk of the study.
- •History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases and/or meningeal metastasis.
- •Previous medication does not meet the requirements.
- •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 .
- •Active autoimmune disease.
- •History of another malignancy .
- •Pleural, abdominal, or pericardial effusion with clinical symptoms or that require drainage treatment.
- •Not suitable to receive study treatment for other conditions as per investigator.
研究组 & 干预措施
Active Comparator: Investigator's Choice of Chemotherapy
Active Comparator
Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol:
eribulin, or vinorelbine or capecitabine or gemcitabine.
干预措施: Chemotherapy (Drug)
Experimental: 9MW2821
Experimental
Participants will receive intravenous (IV) infusion of 9MW2821 as per protocol
干预措施: 9MW2821 (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to approximately 2 years
Time from the date of randomization until the date of death from any cause
次要结局
- Objective Response Rate per investigator(Up to approximately 2 years)
- Duration of Response per investigator(Up to approximately 2 years)
- Time to response per investigator(Up to approximately 2 years)
- Disease Control Rate per investigator(Up to approximately 2 years)
- Progression Free Survival per investigator(Up to approximately 2 years)
- Incidence of adverse events(Up to approximately 2 years)
- Incidence of Anti-Drug Antibody (ADA)(Up to approximately 2 years)
研究者
研究点 (1)
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