NCT06196736招募中3 期
An Open-label, Randomized Phase 3 Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Have Previously Received PD-(L)1 Inhibitor and Platinum-containing Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Progression Free Survival per Blinded Independent Central Review
研究概览
简要总结
The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.
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
- •Histologically confirmed locally advanced or metastatic urothelial cancer, not amenable to resection with curative intent.
- •Subject must have received a platinum containing chemotherapy and PD-(L)1 inhibitor in the metastatic/locally advanced setting. If platinum and/or PD-(L)1 inhibitor was administered in the adjuvant/neoadjuvant setting subject must have progressed during treatment or within 12 months of completion.
- •Subject must have experienced radiographic progression during or after the last treatment regimen.
- •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 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
- •Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, 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, received treatment of ADC with MMAE payload, received prior chemotherapy with all available study therapies in the control arm, any strong CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug.
- •Preexisting treatment related toxicity Grade ≥ 2 (except alopecia and grade 2 endocrine system toxicity with stable replacement therapy).
- •Major surgery within 28 days prior to first dose of study drug.
- •Hemoglobin A1C (HbA1c) ≥ 8%.
- •Preexisting peripheral neuropathy Grade ≥
- •Any live vaccines within 28 days before first dose of study drug or during the study.
- •Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- •Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
- •Central nervous system metastases.
- •History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed.
- •History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
- •Has ocular conditions that may increase the risk of corneal epithelium damage.
- •Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
- •Uncontrolled tumor-related bone pain or spinal cord compression. Patients requiring pain medication must be on a stable regimen for at least 2 weeks before the first dose of study drug.
- •Pleural effusion, ascites or pericardial effusion with syptoms or needed drainage.
- •Condition or situation which may put the subject at significant risk.
研究组 & 干预措施
9MW2821
Experimental
干预措施: 9MW2821 (Drug)
Investigator's Choice of Chemotherapy
Active Comparator
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival per Blinded Independent Central Review
时间窗: Up to 3 years
Time from the date of first randomization to the earliest date of documented disease progression per radiological evidence or death from any cause
Overall Survival
时间窗: Up to 3 years
Time from the date of randomization until the date of death from any cause
次要结局
- Objective Response Rate per Blinded Independent Central Review and investigator(Up to 3 years)
- Duration of Response per Blinded Independent Central Review and investigator(Up to 3 years)
- Time to response per Blinded Independent Central Review and investigator(Up to 3 years)
- Disease Control Rate per Blinded Independent Central Review and investigator(Up to 3 years)
- Progression Free Survival per investigator(Up to 3 years)
- Incidence of Anti-Drug Antibody (ADA)(Up to 3 years)
- Incidence of adverse events(Up to 3 years)
- Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）(Up to 3 years)
- Mean change from baseline in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)(Up to 3 years)
研究者
研究点 (1)
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相关资讯
Mabwell's 9MW2821 Receives Breakthrough Therapy Designation in China for Urothelial Carcinoma- Mabwell's 9MW2821, a Nectin-4 targeted ADC, has been granted Breakthrough Therapy Designation (BTD) in China for urothelial carcinoma by the NMPA's Center for Drug Evaluation.
- The BTD was awarded for 9MW2821 in combination with toripalimab for treatment-naïve, unresectable, locally advanced or metastatic urothelial carcinoma.
- Initial results from 40 patients showed an objective response rate (ORR) of 87.5% and a disease control rate (DCR) of 92.5% with the 9MW2821 and toripalimab combination.
- A Phase III trial is underway comparing 9MW2821 plus toripalimab to chemotherapy in treatment-naïve locally advanced or metastatic urothelial carcinoma patients.last yearMabwell's 9MW2821 and Astellas' Padcev Advance in China for Urothelial Cancer Treatment- Mabwell's 9MW2821 receives Breakthrough Therapy Designation from China's NMPA for advanced urothelial carcinoma post-platinum and PD-(L)1 inhibitor failure.
- Astellas' Padcev (enfortumab vedotin) gains approval in China for locally advanced or metastatic urothelial cancer after prior treatments.
- 9MW2821 shows promising objective response rates (62.2%) and disease control (91.9%) in urothelial carcinoma, according to Phase 1/2 trial data.
- Phase 3 trials are underway for both 9MW2821 and Padcev to further evaluate efficacy and safety in urothelial carcinoma patients.2 years ago