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A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma

2026年9月25日 更新者:Genentech, Inc.

一项评估RO7875913在健康志愿者中的安全性、药代动力学和药效学的I期剂量递增研究

Part A: The purpose of Part A of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants.

Part B: The purpose of Part B of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RO7875913 administered in combination with the T cell-engaging bispecific antibody (TCB) cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).

研究概览

研究类型

介入性

注册 (估计的)

240

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

    • Canterbury
      • Christchurch、Canterbury、新西兰、8011
        • New Zealand Clinical Research - Christchurch

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 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

General:

  • Agreement to adhere to the contraception requirements

Part A:

  • Body weight > 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m^2)

Part B:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Agreement to provide bone marrow biopsy and aspirate samples

Exclusion Criteria:

General:

  • Treatment with any vaccine within 4 weeks prior to initiation of study drug, or vaccination scheduled to occur during the study
  • History or current cardiovascular or pulmonary disease that may limit the ability to respond to systemic infusion/injection reactions
  • Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen
  • History of any malignancy
  • Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
  • Known allergy or hypersensitivity to any component of the RO7875913 formulation

Part A:

  • Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
  • Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
  • Clinically apparent or familial history of autoimmune disease

Part B:

  • Treatment with any systemic chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
  • Treatment with any immunosuppressive medication within 2 weeks prior to first dose of study treatment
  • Absolute plasma cell count exceeding 500/mL or 5% of the peripheral blood white cells

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:随机化
  • 介入模型:顺序分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Part A: RO7875913

Participants will receive RO7875913.

Participants will receive RO7875913 as per the schedule described in the protocol.

安慰剂比较:Part A: Placebo

Participants will receive placebo.

Participants will receive placebo as per the schedule described in the protocol.

实验性的:Part B: RO7875913 with cevostamab

Participants will recieve RO7875913 with cevostamab.

Participants will receive RO7875913 as per the schedule described in the protocol.

Participants will receive cevostamab as per the schedule described in the protocol

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Part A: Percentage of Participants with Adverse Events (AEs)
大体时间:Up to approximately 3 months
Up to approximately 3 months
Part B: Percentage of Participants with Adverse Events (AEs)
大体时间:Up to approximately 2 years
Up to approximately 2 years

次要结果测量

结果测量
大体时间
Part A: Serum concentration of RO7875913
大体时间:Up to Day 76
Up to Day 76
Part A: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
大体时间:Baseline, Up to Day 76
Baseline, Up to Day 76
Part A: Recommended Phase II Dose (RP2D) of RO7875913
大体时间:Up to approximately 3 months
Up to approximately 3 months
Part A: Observed Value of Pharmacodynamic Markers
大体时间:Baseline, up to approximately 3 months
Baseline, up to approximately 3 months
Part B: Serum Concentration of RO7875913
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Serum Concentration of Cevostamab
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Objective Response Rate
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Rate of Very Good Partial Response (VGPR) or Better
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Duration of Response
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Time to First Response
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Time to Best Response
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to RO7875913 During the Treatment Period
大体时间:Up to approximately 2 years
Up to approximately 2 years
Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen
大体时间:Up to approximately 2 years
Up to approximately 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。

调查人员

  • 研究主任:Clinical Trials、Genentech, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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3月11日

初级完成 (估计的)

2030年6月17日

研究完成 (估计的)

2030年6月17日

研究注册日期

首次提交

2026年1月6日

首先提交符合 QC 标准的

2026年1月6日

首次发布 (实际的)

2026年1月15日

研究记录更新

最后更新发布 (实际的)

2026年9月30日

上次提交的符合 QC 标准的更新

2026年9月25日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

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