An Open, Single Arm, Single Center Phase II Clinical Study Evaluating the Efficacy and Safety of RC48-ADC in the Treatment of Metastatic Castration Resistant Prostate Cancer (mCRPC) Progression After Novel Endocrine Therapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- PSA response rate
研究概览
简要总结
This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study.
详细描述
This is a single-arm, open, single-center clinical study to evaluate the efficacy and safety of RC48-ADC in patients with mCRPC who have progressed after NHT. A total of 40 patients with mCRPC with immunohistochemically confirmed HER2 expression who had progressed after treatment with at least one novel endocrine therapy will be included in this study. Participants will receive RC48-ADC intravenous injection (2.0 mg/kg, Q2W) until disease progression or death. During the treatment, participants will evaluate every 4 weeks, including PSA testing every 4 weeks and tumor evaluation according to PCWG3 standards every 8 weeks. If the patient develops disease progression, the treatment will be discontinued and survival follow-up will be conducted every 8 weeks.
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
- •Prostate cancer confirmed by histology;
- •≥ 18 years old;
- •The presence of metastatic lesions confirmed by bone scan and/or CT/MRI and/or PET-CT;
- •ECOG score 0-2;
- •Continuously maintain ADT treatment and maintain testosterone levels ≤ 50ng/dL; The progression of prostate cancer recorded within 6 months prior to screening;
- •Having received at least one NHT in the past before progressing;
- •HER2 IHC 1+, 2+, or 3+;
- •Inability to or refusal docetaxel chemotherapy;
- •Voluntarily join the study;
- •Expected survival time ≥ 6 months;
- •Normal function of main organs;
排除标准
- •Have a history of malignant tumors other than prostate cancer;
- •Previously received allogeneic stem cell or parenchymal organ transplantation;
- •Previously or currently suffering from congenital or acquired immunodeficiency diseases;
- •The patient have a history of allergy to RC48 or paclitaxel, or a history of Hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to excipients of the study drug;
- •Other significant clinical and laboratory abnormalities that affect safety evaluation;
- •Those who are unwilling or unable to take effective contraceptive measures;
- •Subjects with active brain metastasis;
研究组 & 干预措施
Disitamab Vedotin(RC48-ADC)
Disitamab Vedotin(RC48-ADC) :2.0mg/kg，Q2W
干预措施: Disitamab Vedotin（RC48-ADC） (Drug)
结局指标
主要结局
PSA response rate
时间窗: 24 months
The proportion of subjects receiving at least one cycle of treatment with the study drug who had at least a 50% reduction in PSA from baseline and maintained it for more than 21 days (PSA50).
次要结局
- ORR，Objective Response Rate(24 months)
- Overall survival (OS)(From the first dose to death from any cause，up to two years.)
- Progression free survival(From the first dose to the first documentation of disease progression or death, up to two years.)