A Phase 1 Trial of JNJ-98768111, an Antibody Drug Conjugate (ADC) Targeting Human Kallikrein-2 (KLK2) for Advanced Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: JNJ-98768111 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: 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.
Part 1: Number of Participants with Dose-Limiting Toxicities (DLT)
时间窗: 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.
次要结局
- Maximum Observed Concentration (Cmax) of JNJ-98768111(Up to approximately 2 years 7 months)
- Trough Concentration (Ctrough) of JNJ-98768111(Up to approximately 2 years 7 months)
- Time to Maximum Observed Concentration (Tmax) of JNJ-98768111(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(Up to approximately 2 years 7 months)
- Accumulation Ratio of JNJ-98768111(Up to approximately 2 years 7 months)
- Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-98768111(Up to approximately 2 years 7 months)
- Objective Response Rate (ORR)(Up to approximately 2 years 7 months)
- Radiographic Progression-Free Survival (rPFS)(Up to approximately 2 years 7 months)
- Prostate-Specific Antigen (PSA) Response(Up to approximately 2 years 7 months)
- Duration of Response (DOR)(Up to approximately 2 years 7 months)