NCT06551233招募中1 期
A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age≥18 years old before signing the informed consent.
- •Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
- •Subjects refuse or are intolerant to BCG therapy.
- •Subjects must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field.
- •Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.
- •Histological and pathological diagnosis of urothelial carcinoma (with a major component >50%) , with the confirmation of no-muscle invasion.
- •Subjects must be categorized as high-risk NMIBC
- •Subjects refuse or are intolerant to radical cystectomy.
- •Clinical non-metastatic bladder cancer (N0, M0) determined by CT scan.
- •Adequate function of heart, bone marrow, liver, and kidney.
- •Subjects must be willing to take highly effective contraception during the study and 180 days after the last dose of 9MW2821 (a negative serum pregnancy test result within ≤7 days before enrollment for the female).
排除标准
- •History of muscle invasive or metastatic bladder cancer.
- •History of other malignancies within 3 years.
- •Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
- •Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.
- •Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.
- •Persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to NCI-CTCAE v5.
- •Active systemic infections that require treatments within 7 days before the first dose.
- •Severe cardiovascular diseases within 6 months before the first dose.
- •History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- •History of autoimmune diseases.
- •Serum virology tests: positive results for HBsAg or HBcAb, with positive HBV-DNA copies (≥500IU/mL); positive HCV-Ab results, with positive HCV-RNA results; positive HIV-Ab results.
- •Prior treatment with drugs targeted Nectin-4 or MMAE-conjugated ADC.
研究组 & 干预措施
dose escalation and expansion
Experimental
Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy
干预措施: 9MW2821 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: up to 12 months
assess the incidence of AE/SAE
RP2D and MTD
时间窗: up to 12 months
Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur.
次要结局
- DFS(Up to 20 months)
- Proportion of radical cystectomy(Up to 20 months)
- DFS rate of 12 months(Up to 12 months)
- DoR of CR(Up to 20 months)
- CR rate of 3/6/12 months(Up to 12 months)
- Duration to radical cystectomy(Up to 20 months)
- Biomarker parameter(Up to 20 months)
研究者
Hongqian Guo
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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