NCT07393542招募中3 期
An Open Label, Randomized, Multicenter, Phase III Study of SHR-A2102 in Combination With Adebrelimab Versus Gemcitabine in Combination With Cisplatin/Carboplatin in Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma (NEC-UC2)
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
- 453
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS), assessed by BICR
研究概览
简要总结
The study is being conducted to evaluate the efficacy of SHR-A2102 with adebrelimab versus gemcitabine in combination with cisplatin/carboplatin in previously untreated locally advanced or metastatic urothelial carcinoma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to sign the informed consent form in writing.
- •Female or male, 18 to 80 years of age (both inclusive).
- •ECOG performance status of 0 or
- •Expected survival of≥ 3 months.
- •Histologically confirmed diagnosis of urothelial carcinoma with radiographic or other confirmation of locally advanced unresectable or metastatic disease.
- •No prior systemic therapy for locally advanced or metastatic disease.
- •Able to provide archived or fresh tumor tissue for Nectin-4 and PD-L1 expression.
- •According to RECIST v1.1, there must be at least one measurable lesion;
- •Tolerant to cisplatin or carboplatin.
- •Adequate organ functions.
- •Agree to use medically approved contraceptive measures.
排除标准
- •Planned to receive any other anti-tumor therapy during the study.
- •Received other investigational products or treatments not yet marketed within 4 weeks.
- •Have received systemic anti-tumor treatment within 4 weeks;have received prior anti-tumor Chinese patent medicine treatment within 2 weeks; palliative radiotherapy or local therapy within 2 weeks.
- •Previously received therapy with an antibody-drug conjugate that meets any one of the following characteristics: targeting Nectin-4; containing irinotecan or its derivatives and acting as a topoisomerase I inhibitor.
- •Prior treatment with immune checkpoint inhibitors.
- •Major surgical procedure other than diagnostic or biopsy within 4 weeks, requiring elective surgery during the trial.
- •Active autoimmune disease requiring systemic treatment within 2 years.
- •Have experienced adverse events caused by previous anti-tumor treatments that have not recovered to grade ≤1 as per NCI-CTCAE v5.
- •Uncontrolled central nervous system metastases or carcinomatous meningitis.
- •Subjects with clinical symptoms or serous cavity effusion requiring puncture drainage.
- •Other malignancies within 5 years.
- •History of clinically significant pulmonary disease or any such disease suggested by chest imaging at screening.
- •Serious infections requiring intravenous antibiotics, antivirals, or antifungals for control.
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •History of immunodeficiency, or history of organ transplant.
- •Have experienced arteriovenous thrombosis or cardiovascular and cerebrovascular accidents within 6 months.
- •Subjects with clinically significant hemorrhage within 3 months.
- •Glycosylated hemoglobin (HbA1c) ≥ 8%.
- •Have serious cardiovascular and cerebrovascular diseases.
- •Allergic reaction to any component of the study treatment.
- •Subjects with active pulmonary tuberculosis.
- •History of severe dry eye, active keratitis, or corneal ulcer, or other conditions.
- •Female Subjects who are pregnant or planning to become pregnant during the study.
- •Other conditions unsuitable into the study.
研究组 & 干预措施
Treatment group 1
Experimental
SHR-A2102 and Adebrelimab
干预措施: SHR-A2102 and Adebrelimab (Drug)
Treatment group 3
Active Comparator
Gemcitabine and cisplatin / carboplatin
干预措施: Gemcitabine and cisplatin / carboplatin (Drug)
结局指标
主要结局
Progression-free survival(PFS), assessed by BICR
时间窗: up to 50 months
次要结局
- ORR, assessed by investigator(up to 50 months)
- DCR, assessed by investigator(up to 50 months)
- DoR, assessed by investigator(up to 50 months)
- Adverse event(AE)(up to 50 months)
- serious adverse event(SAE)(up to 50 months)
- Overall Survival(OS)(up to 50 months)
- Objective response rate(ORR), assessed by BICR(up to 50 months)
- Disease control rate(DCR), assessed by BICR(up to 50 months)
- Duration of response(DoR), assessed by BICR(up to 50 months)
- PFS, assessed by investigator(up to 50 months)
研究者
研究点 (1)
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