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REGN5678（抗 PSMAxCD28）联合 Cemiplimab（抗 PD-1）治疗转移性去势抵抗性前列腺癌患者的研究

2026年11月3日 更新者：Regeneron Pharmaceuticals

REGN5678（抗 PSMAxCD28）联合 Cemiplimab（抗 PD-1）治疗转移性去势抵抗性前列腺癌患者的 1/2 期研究

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug[s]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.

The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.

This study is looking at several other research questions, including:

  1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab
  2. How REGN5678 alone or in combination with cemiplimab works in the body
  3. How much REGN5678 and/or cemiplimab are present in the blood
  4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

345

阶段

  • 阶段2
  • 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

学习地点

  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
        • 招聘中
        • Banner MD Anderson Cancer Center
      • Phoenix、Arizona、美国、85054
        • 招聘中
        • Mayo Clinic
      • Tucson、Arizona、美国、85724
        • 招聘中
        • University of Arizona
    • California
      • Santa Monica、California、美国、90404
        • 招聘中
        • John Wayne Cancer Institute (JWCI)
    • Colorado
      • Denver、Colorado、美国、80218
        • 招聘中
        • Sarah Cannon Research Institute (SCRI)
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • 招聘中
        • Yale University Hospital
    • Florida
      • Jacksonville、Florida、美国、32224
        • 招聘中
        • Mayo Clinic Jacksonville
      • Tampa、Florida、美国、33612
        • 招聘中
        • Moffitt Cancer Center - McKinley Drive
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Massachusetts General Hospital
    • Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Health
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic
    • New York
      • New York、New York、美国、10029
        • 招聘中
        • Icahn School of Medicine at Mount Sinai
      • New York、New York、美国、10461
        • 招聘中
        • Montefiore Medical Center
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Health Perlmutter Cancer Center
      • New York、New York、美国、10032
        • 招聘中
        • Columbia University - The Trustees of Columbia University in the City of New York
      • Rochester、New York、美国、14642
        • 招聘中
        • University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
    • Ohio
      • Columbus、Ohio、美国、43210
        • 招聘中
        • James Cancer Hospital and Solove Research Institute
    • Oregon
      • Portland、Oregon、美国、97213
        • 撤销
        • Providence Portland Medical Center
      • Portland、Oregon、美国、97239
        • 招聘中
        • Oregon Health & Science University (3485 S. Bond)
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • 招聘中
        • Thomas Jefferson University Hospital
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • 招聘中
        • Lifespan Cancer Institute
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • MD Anderson Cancer Center
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • 招聘中
        • Emily Couric Clinical Cancer Center
    • West Virginia
      • Morgantown、West Virginia、美国、26506
        • 招聘中
        • West Virginia University
  • 韩国
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center
      • Seoul、韩国、03722
        • 招聘中
        • Yonsei University - Severance Hospital - Colorectal Cancer Clinic
    • Gyeonggi-do
      • Suwon、Gyeonggi-do、韩国、16247
        • 招聘中
        • The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center

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

Key Inclusion Criteria:

mCRPC cohorts (men):

  1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.

  2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.

  3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy [ADT]) including at least:

    1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
    2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol

ccRCC cohorts (men and women):

  1. Histologically or cytologically confirmed RCC with a clear-cell component.
  2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
  3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) [PD-1]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor

Key Exclusion Criteria:

  1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol
  2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
  3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
  4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
  5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
  6. Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
  7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol
  8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
  9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

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：mCRPC - dose escalation cohort

REGN5678 with or without cemiplimab
药品：REGN5678

Administered as per the protocol

其他名称：
  • 内扎斯托米格
药品：Cemiplimab

Administered as per the protocol

其他名称：
  • REGN2810
  • 利比塔约
实验性的：mCRPC - dose expansion cohort

REGN5678 with or without cemiplimab
药品：REGN5678

Administered as per the protocol

其他名称：
  • 内扎斯托米格
实验性的：ccRCC - dose escalation cohort

REGN5678 with or without cemiplimab
药品：REGN5678

Administered as per the protocol

其他名称：
  • 内扎斯托米格
药品：Cemiplimab

Administered as per the protocol

其他名称：
  • REGN2810
  • 利比塔约
实验性的：ccRCC - dose expansion cohort

REGN5678 with or without cemiplimab
药品：REGN5678

Administered as per the protocol

其他名称：
  • 内扎斯托米格

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
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Adverse Event of Special Interests (AESIs)
大体时间：Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
大体时间：Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Number of participants with Grade ≥3 laboratory abnormalities
大体时间：Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence of Dose-Limiting Toxicities (DLTs)
大体时间：First dose through day 42 of last participant in each dose level

Dose Escalation Phase
First dose through day 42 of last participant in each dose level
Concentration of REGN5678 in serum over time
大体时间：Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
大体时间：Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)
大体时间：Through study completion, up to 5 years

Dose Expansion Phase - mCRPC cohort
Through study completion, up to 5 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
大体时间：Through study completion, up to 5 years

Dose Expansion Phase - ccRCC cohort
Through study completion, up to 5 years

次要结果测量

结果测量
措施说明
大体时间
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
大体时间：Through study completion, up to 5 years

Dose Escalation Phase - mCRPC cohort
Through study completion, up to 5 years
ORR per RECIST 1.1 criteria
大体时间：Through study completion, up to 5 years

Dose Escalation Phase - ccRCC cohort
Through study completion, up to 5 years
Incidence and severity of TEAEs
大体时间：Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of AESIs
大体时间：Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of SAEs
大体时间：Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Number of participants with grade ≥3 laboratory abnormalities
大体时间：Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in serum over time
大体时间：Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
大体时间：Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Percentage of participants with ≥50% decline of PSA
大体时间：Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases - mCRPC cohorts
Through study completion, up to 5 years
Percentage of participants with ≥90% decline of PSA
大体时间：Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases- mCRPC cohorts
Through study completion, up to 5 years
Presence or absence of antibodies against REGN5678
大体时间：Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 years
Presence or absence of antibodies against cemiplimab
大体时间：Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 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

Regeneron Pharmaceuticals

调查人员

  • 研究主任：Clinical Trials Management、Regeneron Pharmaceuticals

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)

2019年8月12日

初级完成 (估计的)

2027年11月15日

研究完成 (估计的)

2027年11月15日

研究注册日期

首次提交

2019年5月30日

首先提交符合 QC 标准的

2019年5月30日

首次发布 (实际的)

2019年6月3日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3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

  • R5678-ONC-1879

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

All individual patient data (IPD) that underlie publicly available results will be considered for sharing

IPD 共享时间框架

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 共享访问标准

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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.

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