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JNJ-87562761 在复发性或难治性多发性骨髓瘤参与者中的研究

2026年11月2日 更新者：Janssen Research & Development, LLC

JNJ-87562761 治疗复发/难治性多发性骨髓瘤的 1 期、首次人体、开放标签、剂量递增研究

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2D[s]) of JNJ-87562761 in Part 1 (dose escalation), and to determine the safety and tolerability at RP2D in Part 2 (dose expansion) in participants with multiple myeloma (MM) whose disease has come back after treatment (relapsed) or hasn't responded to treatment (refractory).

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

17

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。

学习地点

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal、Quebec、加拿大、H3T 1E2
        • Jewish General Hospital
  • 台湾
      • Kaohsiung City、台湾、833
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung、台湾、404
        • China Medical University Hospital
      • Tainan、台湾、70403
        • National Cheng Kung University Hospital
      • Taipei、台湾、100225
        • National Taiwan University Hospital
  • 西班牙
      • Badalona、西班牙、08916
        • Hosp. Univ. Germans Trias I Pujol
      • Barcelona、西班牙、08036
        • Hosp Clinic de Barcelona
      • Madrid、西班牙、28040
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona、西班牙、31008
        • Clinica Univ. de Navarra
      • Salamanca、西班牙、37007
        • Hosp Clinico Univ de Salamanca
  • 韩国
      • Seoul、韩国、03080
        • Seoul National University Hospital
      • Seoul、韩国、05505
        • Asan Medical Center
      • Seoul、韩国、06351
        • Samsung Medical Center
      • Seoul、韩国、137 701
        • The Catholic University of Korea Seoul St Marys Hospital

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Relapsed, refractory multiple myeloma with measurable disease defined as: (a) Serum monoclonal paraprotein (M-protein) level greater than (>)0.5 grams per deciliter (g/dL); or (b) Urine M-protein level >200 milligrams per 24 hours (mg/24 hours); or (c) Light chain multiple myeloma: serum immunoglobulin free light chain (FLC) >10 milligrams per deciliter (mg/dL) and abnormal serum immunoglobulin kappa-lambda FLC ratio
  • Must have had prior therapy including a proteasome inhibitor, immunomodulatory agent and anti-CD38 therapy
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Have an estimated glomerular filtration rate (eGFR), of > 30 millilitres (mL)/min/1.73 meter square (m^2) computed per 2021 chronic kidney disease epidemiology collaboration (CKD-EPI) creatinine equation
  • While on study treatment and for 6 months after the last dose of study treatment, a participant must: (a) Not breastfeed or be pregnant; (b) Not donate gametes (that is, eggs or sperm) or freeze for future use for the purposes of assisted reproduction; (c) Wear an external condom

Exclusion Criteria:

  • Active plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or immunoglobulin light chain amyloidosis
  • Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline level or to less than or equal to (<=) Grade 1 (except alopecia, tissue post-RT fibrosis, or Grade < 3 peripheral neuropathy)
  • Received a cumulative dose of corticosteroids equivalent to greater than or equal to (>=) 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Prior antitumor therapy in the specified time frame prior to the first dose of study treatment: (Targeted therapy, epigenetic therapy, monoclonal antibody treatment, or treatment with an investigational drug or an invasive investigational medical device or conventional chemotherapy within 21 days, gene-modified adoptive cell therapy or treatment with anti-CD38 directed therapies within 3 months, proteasome inhibitor [PI] therapy or radiotherapy within 14 days, or immunomodulatory drug (IMiD) agent therapy within 7 days)
  • Following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection (participants with a detectable viral load or low CD4 count), active hepatitis B or C infection, active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment, serious uncontrolled ongoing viral or bacterial or systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera [etc.])

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-87562761

Participants will receive JNJ-87562761 during the Part 1 (Dose escalation) to determine the recommended phase 2 dose (RP2D) regimen(s). The dose will be escalated sequentially until the RP2D regimen(s) have been identified. In Part 2 (Dose expansion) participants will receive JNJ-87562761 at the RP2D regimen(s) determined in Part 1.
药品：JNJ-87562761

JNJ-87562761 will be administered.

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
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
大体时间：up to approximately 3 years

DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
up to approximately 3 years
Part 1 and 2: Number of Participants with Adverse Events (AEs)
大体时间：up to approximately 3 years

Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
up to approximately 3 years
Part 2: Number of Participants with Clinically Significant Abnormal Laboratory Values
大体时间：up to approximately 3 years

Number of participants with clinically significant abnormal laboratory values (hematology or chemistry) will be reported.
up to approximately 3 years

次要结果测量

结果测量
措施说明
大体时间
Serum Concentration of JNJ-87562761
大体时间：up to approximately 3 years

Serum samples will be analyzed to determine concentrations of JNJ-87562761.
up to approximately 3 years
Pharmacokinetic (PK) Parameters of JNJ-87562761
大体时间：up to approximately 3 years

PK parameters for JNJ-87562761 will be evaluated.
up to approximately 3 years
Number of Participants with Presence of Anti-JNJ-87562761 Antibodies
大体时间：up to approximately 3 years

Number of participants with presence of anti-JNJ-87562761 antibodies will be reported.
up to approximately 3 years
Percentage of Participants with Response
大体时间：up to approximately 3 years

Overall response is defined as a best response of partial response (PR) or better as assessed according to the International Myeloma Working Group (IMWG) 2016 response criteria.
up to approximately 3 years
Percentage of Participants Who Achieve Very Good Partial Response (VGPR) or Better
大体时间：up to approximately 3 years

VGPR or better response is defined as the percentage of participants who achieve a best response of VGPR or better as assessed by IMWG 2016 response criteria.
up to approximately 3 years
Percentage of Participants Who Achieve Complete Response (CR) or Better
大体时间：up to approximately 3 years

CR or better response is defined as percentage of participants who achieve a best response of CR or better as assessed by IMWG 2016 response criteria.
up to approximately 3 years
Percentage of Participants Who Achieve Stringent Complete Response (sCR)
大体时间：up to approximately 3 years

sCR is defined as the percentage of participants who achieve a best response of sCR as assessed by IMWG 2016 response criteria.
up to approximately 3 years
Duration of Response (DOR)
大体时间：up to approximately 3 years

DOR is defined for participants who achieve a response of PR or better as the time from the first efficacy evaluation at which the participant met all criteria for a response of PR or better to the time of first documented evidence of progressive disease or death, assessed by IMWG 2016 response criteria.
up to approximately 3 years
Time to Response (TTR)
大体时间：up to approximately 3 years

TTR is defined for participants who achieve a response of PR or better as the time from the first dose of study drug to the time of the first efficacy evaluation at which the participant met all criteria for a response of PR or better, assessed by IMWG 2016 response criteria.
up to approximately 3 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

Janssen Research & Development, LLC

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)

2024年12月19日

初级完成 (估计的)

2027年11月3日

研究完成 (估计的)

2027年11月15日

研究注册日期

首次提交

2024年9月18日

首先提交符合 QC 标准的

2024年9月18日

首次发布 (实际的)

2024年9月19日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 87562761MMY1001
  • 87562761MMY1001 (其他标识符：Janssen Research & Development, LLC)
  • 2024-513439-25-00 (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 www.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

不

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.

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