A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma
2026年6月4日 更新者：Akeso
A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma
This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.
研究概览
研究类型
介入性
注册 (估计的)
132
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ting Liu
- 电话号码：+86 (0760) 8987 3999
- 邮箱：clinicaltrials@akesobio.com
学习地点
-
-
-
Shanghai、中国
- Fudan University Shanghai Cancer Center
-
接触：
- Dingwei Ye
- 电话号码：021-64175590
- 邮箱：dwyeli@163.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Be able to understand and voluntarily sign the written informed consent form.
- Age 18-75.
- ECOG PS 0 or 1.
- Expected lifespan ≥3 months.
- Histologically or cytologically documented Urothelial carcinoma.
- At least one measurable lesion according to RECIST v1.1.
- Sufficient organ function.
Exclusion Criteria:
- Having other active malignancies within 3 years.
- Currently participating in another interventional clinical study.
- Presence of active metastases to the central nervous system.
- Prior chemotherapy agent targeting topoisomerase I .
- Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.
- Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.
- Patients with active autoimmune diseases requiring systemic treatment within 2 years.
- Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.
- Previous history of severe hypersensitivity reactions.
- Patients with a history of mental illness and incapacitated or limited capacity.
- Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm A
AK146D1 combined with AK112
|
AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate
AK112 Injection is a PD-1/VEGF bispecific antibody
|
|
实验性的：Arm B
AK146D1 mono
|
AK146D1 for injection is an antiTrop2/Nectin4 bispecific antibody-drug conjugate
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with dose limiting toxicities(DLTs)
大体时间：During the first 3 weeks of treatment
|
DLTs are defined as toxicities that meet predefined severity criteria, and assessed as having a suspected relationship to study drug
|
During the first 3 weeks of treatment
|
|
Objective Response Rate(ORR)
大体时间：Up to 2 years
|
ORR is the proportion of participants with complete response(CR) or partial response(PR)
|
Up to 2 years
|
|
Number of participants with adverse events (AEs)
大体时间：From the time of informed consent signed through 90 days after the last dose
|
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
|
From the time of informed consent signed through 90 days after the last dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression Free Survival(PFS)
大体时间：Up to 2 years
|
PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause,whichever occurs first.
|
Up to 2 years
|
|
Disease Control Rate(DCR)
大体时间：Up to 2 years
|
DCR is defined as the proportion of participants with CR, PR, or SD
|
Up to 2 years
|
|
Duration of response(DoR)
大体时间：Up to 2 years
|
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
|
Up to 2 years
|
|
Time to response(TTR)
大体时间：Up to 2 years
|
TTR is defined as the time to objective response
|
Up to 2 years
|
|
Overall survival(OS)
大体时间：Up to 2 years
|
OS is defined as the time from the first dose to death from any cause.
|
Up to 2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月22日
初级完成 (估计的)
2028年8月24日
研究完成 (估计的)
2028年8月24日
研究注册日期
首次提交
2026年6月4日
首先提交符合 QC 标准的
2026年6月4日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年6月9日
上次提交的符合 QC 标准的更新
2026年6月4日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.