A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
2026年8月27日 更新者:Janssen Research & Development, LLC
A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer
The purpose of Part 1 of this study is to find out how safe JNJ-98768111 is and the most suitable dose (recommended phase 2 dose [RP2D]) regimen(s) of JNJ-98768111.
The purpose of Part 2 of this study is to find out how safe JNJ-98768111 is at the RP2D regimen(s) in participants with advanced prostate cancer (cancer of the prostate, a male reproductive gland found below the bladder, which has spread extensively to other parts of the body).
研究概览
研究类型
介入性
注册 (估计的)
100
阶段
- 阶段1
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:Study Contact
- 电话号码:844-434-4210
- 邮箱:Participate-In-This-Study1@its.jnj.com
学习地点
-
-
Florida
-
Sarasota、Florida、美国、34232
- 招聘中
- Florida Cancer Specialists & Research Institute
-
-
Michigan
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Grand Rapids、Michigan、美国、49546
- 招聘中
- START MidWest
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Utah
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West Valley City、Utah、美国、84119
- 招聘中
- START Mountain Region
-
-
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:
- a. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine features is permitted. b. Measurable or evaluable disease (metastatic prostate cancer) based on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan. Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy. c. Serum prostate-specific antigen (PSA) value greater than or equal to (>=) 2 nanograms per milliliters (ng/mL). d. Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of trial drug and must continue this therapy throughout the treatment phase; e. Castrate levels of serum testosterone as defined in the protocol, prior to the first dose of trial intervention; f. Progressive metastatic disease following their most recent line of therapy. Disease progression will be defined by at least one of the following: PSA progression, radiographic progression according to response evaluation criteria in solid tumors (RECIST v1.1), or progressive bone disease according to prostate cancer working group 3 (PCWG3) criteria
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Agree to all of the following during the trial and for 6 months after the last dose of trial drug: a. Use a highly effective method of contraception; b. Wear a condom when engaging in any activity that allows for passage of ejaculate to another person; c. Not to donate sperm or freeze for future use for the purpose of reproduction; d. Not plan to father a child. In addition, the participant should be advised of the benefit for a female partner to use a highly effective method of contraception
- Sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the trial and is willing to participate in the trial
Exclusion criteria:
- Active central nervous system (CNS) involvement
- Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels
- External beam radiation therapy to soft tissue lesions within 14 days prior to start of trial intervention
- History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
- History of solid organ or bone marrow transplantation
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:不适用
- 介入模型:顺序分配
- 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:JNJ-98768111
Participants in Part 1 of the study will receive escalating doses of JNJ-98768111 to identify the putative recommended phase 2 dose (pRP2D) regimen(s).
Participants in Part 2 of the study will receive JNJ-98768111 at the pRP2D regimen(s) determined in Part 1.
|
JNJ-98768111 will be administered intravenously.
|
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 Adverse Events (AEs)
大体时间:Up to approximately 2 years 7 months
|
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the treatment.
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Up to approximately 2 years 7 months
|
|
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
大体时间:From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)
|
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
Other DLT criteria includes any related toxicity resulting in permanent treatment discontinuation or a delay in dose administration greater than (>)14 days and any death not clearly due to the underlying disease or non-trial intervention-related causes.
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From first administration of trial intervention to the pre-dose assessment of the second cycle (up to approximately 2 years and 7 months)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Observed Concentration (Cmax) of JNJ-98768111
大体时间:Up to approximately 2 years 7 months
|
Cmax of JNJ-98768111 will be reported.
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Up to approximately 2 years 7 months
|
|
Trough Concentration (Ctrough) of JNJ-98768111
大体时间:Up to approximately 2 years 7 months
|
Ctrough of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Time to Maximum Observed Concentration (Tmax) of JNJ-98768111
大体时间:Up to approximately 2 years 7 months
|
Tmax of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Area Under the Concentration-Time Curve from Time 0 to End of Dosing Interval (AUC [0-tau]) of JNJ-98768111
大体时间:Up to approximately 2 years 7 months
|
AUC0-tau of JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Accumulation Ratio of JNJ-98768111
大体时间:Up to approximately 2 years 7 months
|
Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC [0-24]) value at steady state divided by AUC (0-24) value after first dose.
|
Up to approximately 2 years 7 months
|
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Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111
大体时间:Up to approximately 2 years 7 months
|
Number of participants with antibodies to JNJ-98768111 will be reported.
|
Up to approximately 2 years 7 months
|
|
Objective Response Rate (ORR)
大体时间:Up to approximately 2 years 7 months
|
ORR is defined as the percentage of participants with measurable disease who have a partial response (PR) or better without evidence of bone progression according to prostate cancer working group 3 (PCWG3).
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Up to approximately 2 years 7 months
|
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Radiographic Progression-Free Survival (rPFS)
大体时间:Up to approximately 2 years 7 months
|
rPFS is defined as the time from the date of first dose until the date of objective disease progression or death, whichever comes first.
|
Up to approximately 2 years 7 months
|
|
Prostate-Specific Antigen (PSA) Response
大体时间:Up to approximately 2 years 7 months
|
PSA response rate is defined as the percentage of participants with a decline in PSA of 50% or more from baseline which is sustained for greater than or equal to (>=) 3 weeks.
|
Up to approximately 2 years 7 months
|
|
Duration of Response (DOR)
大体时间:Up to approximately 2 years 7 months
|
DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
|
Up to approximately 2 years 7 months
|
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。
调查人员
- 研究主任:Janssen Research & Development LLC Clinical Trial、Janssen Research & Development, LLC
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 (实际的)
2026年8月5日
初级完成 (估计的)
2029年3月16日
研究完成 (估计的)
2029年3月16日
研究注册日期
首次提交
2026年7月31日
首先提交符合 QC 标准的
2026年7月31日
首次发布 (实际的)
2026年8月5日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 98768111PCR1001
- 2026-525894-37-00 (注册表标识符:EUCT number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
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.