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MK-2870 单独或联合化疗治疗胃肠道癌症的临床研究 (MK-9999-02A)

2026年10月28日 更新者：Merck Sharp & Dohme LLC

评估 MK-2870 单一疗法或与其他抗癌药物联合治疗胃肠道癌症的安全性和有效性的 1/2 期研究

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:

  • About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it
  • How many people have the cancer respond (get smaller or go away) to treatment

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)

220

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

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 主动，不招人
        • Beijing Cancer hospital-Digestive Oncology ( Site 0061)
    • Fujian
      • Fuzhou、Fujian、中国、350025
        • 招聘中
        • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
        • 接触：
          • Study Coordinator
          • 电话号码：0591-22859663
    • Hubei
      • Wuhan、Hubei、中国、430024
        • 主动，不招人
        • Wuhan Union Hospital Cancer Center. ( Site 0064)
    • Hunan
      • Changsha、Hunan、中国、410013
        • 主动，不招人
        • Hunan Cancer Hospital-intervention department ( Site 0066)
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200127
        • 主动，不招人
        • Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • 招聘中
        • West China Hospital, Sichuan University ( Site 0068)
        • 接触：
          • Study Coordinator
          • 电话号码：028-85423203
  • 加拿大
    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L6
        • 招聘中
        • The Ottawa Hospital Cancer Centre ( Site 0027)
        • 接触：
          • Study Coordinator
          • 电话号码：613-737-7700 x70185
    • Quebec
      • Montreal、Quebec、加拿大、H2X 0A9
        • 招聘中
        • Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
        • 接触：
          • Study Coordinator
          • 电话号码：5148908000
      • Montreal、Quebec、加拿大、H4A 3J1
        • 主动，不招人
        • McGill University Health Centre ( Site 0023)
  • 台湾
      • Taichung、台湾、404332
        • 主动，不招人
        • China Medical University Hospital ( Site 0223)
      • Tainan、台湾、704
        • 主动，不招人
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
      • Taipei、台湾、10002
        • 主动，不招人
        • National Taiwan University Hospital-Oncology ( Site 0225)
      • Taipei、台湾、112
        • 主动，不招人
        • Taipei Veterans General Hospital ( Site 0221)
      • Taoyuan、台湾、33305
        • 主动，不招人
        • Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06800
        • 完全的
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
      • Ankara、土耳其（türkiye）、06230
        • 完全的
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
  • 意大利
      • Roma、意大利、00168
        • 招聘中
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
        • 接触：
          • Study Coordinator
          • 电话号码：390458128116
    • Lombardy
      • Milan、Lombardy、意大利、20133
        • 招聘中
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
        • 接触：
          • Study Coordinator
          • 电话号码：390223903807
      • Milan、Lombardy、意大利、20162
        • 招聘中
        • ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
        • 接触：
          • Study Coordinator
          • 电话号码：390264442291
  • 日本
    • Chiba
      • Kashiwa、Chiba、日本、277-8577
        • 招聘中
        • National Cancer Center Hospital East ( Site 0121)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-4-7133-1111
    • Kanagawa
      • Yokohama、Kanagawa、日本、241-8515
        • 招聘中
        • Kanagawa Cancer Center ( Site 0122)
        • 接触：
          • Study Coordinator
          • 电话号码：+81-45-520-2222
  • 智利
    • Araucania
      • Temuco、Araucania、智利、4800827
        • 招聘中
        • James Lind Centro de Investigacion del Cancer ( Site 0048)
        • 接触：
          • Study Coordinator
          • 电话号码：+56452982404
    • Region M. de Santiago
      • Providencia、Region M. de Santiago、智利、7500921
        • 主动，不招人
        • FALP-UIDO ( Site 0041)
      • Santiago、Region M. de Santiago、智利、7620002
        • 招聘中
        • Clínica UC San Carlos de Apoquindo ( Site 0043)
        • 接触：
          • Study Coordinator
          • 电话号码：+56227548924
      • Santiago、Region M. de Santiago、智利、8420383
        • 主动，不招人
        • Bradfordhill-Clinical Area ( Site 0047)
  • 澳大利亚
    • New South Wales
      • Westmead、New South Wales、澳大利亚、2145
        • 主动，不招人
        • Westmead Hospital ( Site 0003)
    • Queensland
      • Brisbane、Queensland、澳大利亚、4029
        • 主动，不招人
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
    • Victoria
      • East Melbourne、Victoria、澳大利亚、3002
        • 主动，不招人
        • Epworth Freemasons ( Site 0005)
      • Frankston、Victoria、澳大利亚、3199
        • 主动，不招人
        • Frankston Hospital-Oncology and Haematology ( Site 0004)
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
        • 主动，不招人
        • One Clinical Research ( Site 0002)
  • 瑞士
    • Canton Ticino
      • Bellinzona、Canton Ticino、瑞士、6500
        • 招聘中
        • Ospedale Regionale Bellinzona e Valli ( Site 0201)
        • 接触：
          • Study Coordinator
          • 电话号码：+41918119039
    • Canton of Geneva
      • Geneva、Canton of Geneva、瑞士、1211
        • 招聘中
        • Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
        • 接触：
          • Study Coordinator
          • 电话号码：+41223729862
  • 美国
    • California
      • Los Angeles、California、美国、90095
        • 招聘中
        • UCLA ( Site 0317)
        • 接触：
          • Study Coordinator
          • 电话号码：310-633-8400
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • University of Colorado Anschutz Medical Campus ( Site 0299)
        • 接触：
          • Study Coordinator
          • 电话号码：303-724-8644
      • Aurora、Colorado、美国、80045
        • 招聘中
        • University of Colorado Anschutz Medical Campus ( Site 0325)
        • 接触：
          • Study Coordinator
          • 电话号码：720-848-0300
      • Aurora、Colorado、美国、80045
        • 招聘中
        • University of Colorado Anschutz Medical Campus ( Site 0326)
        • 接触：
          • Study Coordinator
          • 电话号码：720-848-0300
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20016
        • 主动，不招人
        • Sibley Memorial Hospital ( Site 0310)
    • Florida
      • Gainesville、Florida、美国、32610
        • 招聘中
        • University of Florida College of Medicine ( Site 0281)
        • 接触：
          • Study Coordinator
          • 电话号码：352-265-5121
      • Miami Beach、Florida、美国、33140
        • 完全的
        • Mount Sinai Cancer Center ( Site 0287)
    • Georgia
      • Marietta、Georgia、美国、30060
        • 完全的
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
    • New York
      • Mineola、New York、美国、11501
        • 招聘中
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
        • 接触：
          • Study Coordinator
          • 电话号码：646-599-4083
      • New York、New York、美国、10016
        • 招聘中
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
        • 接触：
          • Study Coordinator
          • 电话号码：212-731-6000
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • University of Texas MD Anderson Cancer Center ( Site 0316)
        • 接触：
          • Study Coordinator
          • 电话号码：713-792-2828
    • Virginia
      • Roanoke、Virginia、美国、24014
        • 招聘中
        • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
        • 接触：
          • Study Coordinator
          • 电话号码：540-491-2240
    • Wisconsin
      • Madison、Wisconsin、美国、53792
        • 招聘中
        • University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
        • 接触：
          • Study Coordinator
          • 电话号码：800-622-8922
  • 英国
      • Coventry、英国、CV2 2DX
        • 招聘中
        • University Hospital Coventry & Warwickshire ( Site 0266)
        • 接触：
          • Study Coordinator
          • 电话号码：02476967485
    • England
      • London、England、英国、E1 1RD
        • 招聘中
        • Barts Health NHS Trust ( Site 0263)
        • 接触：
          • Study Coordinator
          • 电话号码：07918804584
      • London、England、英国、NW3 2QG
        • 招聘中
        • Royal Free Hospital ( Site 0262)
        • 接触：
          • Study Coordinator
          • 电话号码：02077940500 ext38682
  • 西班牙
      • Barcelona、西班牙、08035
        • 主动，不招人
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
    • Madrid, Comunidad de
      • Madrid、Madrid, Comunidad de、西班牙、28009
        • 招聘中
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
        • 接触：
          • Study Coordinator
          • 电话号码：914269070
    • Principality of Asturias
      • Oviedo、Principality of Asturias、西班牙、33011
        • 主动，不招人
        • Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
  • 韩国
      • Seoul、韩国、03080
        • 招聘中
        • Seoul National University Hospital ( Site 0161)
        • 接触：
          • Study Coordinator
          • 电话号码：82-2-2072-0701
      • Seoul、韩国、05505
        • 招聘中
        • Asan Medical Center ( Site 0163)
        • 接触：
          • Study Coordinator
          • 电话号码：+82 2 3010 3945
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center ( Site 0162)
        • 接触：
          • Study Coordinator
          • 电话号码：+82234103549
      • Seoul、韩国、03722
        • 主动，不招人
        • Severance Hospital, Yonsei University Health System ( Site 0164)

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:

The main inclusion criteria include but are not limited to the following:

  • Has one of the following cancers:

    • Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer
    • Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
    • Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
    • Advanced and/or unresectable BTC and has not received prior therapy for the cancer

  • For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of severe eye disease
  • For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
  • History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening

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：Sacituzumab tirumotecan + Chemotherapy

Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
生物：Sacituzumab tirumotecan

Given by IV infusion.

其他名称：
  • SKB264
  • MK-2870
药品：Fluorouracil (5-FU)

5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.

药品：Leucovorin (LV) or levoleucovorin

LV or levoleucovorin is administered by IV infusion every 2 weeks.

药品：Rescue medication

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

药品：Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
实验性的：Sacituzumab tirumotecan

Participants will receive sacituzumab tirumotecan in one of two dose levels every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
生物：Sacituzumab tirumotecan

Given by IV infusion.

其他名称：
  • SKB264
  • MK-2870
药品：Rescue medication

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

药品：Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
实验性的：Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.
生物：Sacituzumab tirumotecan

Given by IV infusion.

其他名称：
  • SKB264
  • MK-2870
药品：Rescue medication

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

药品：Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.

药品：Cisplatin

Given by IV infusion.

其他名称：
  • 铂金®
生物：Pembrolizumab

Given by IV infusion.

其他名称：
  • MK-3475
  • 可瑞达®

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 Who Experience a Dose-limiting Toxicity (DLT)
大体时间：Up to approximately 4 weeks

A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
Up to approximately 4 weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
大体时间：Up to approximately 63 months

An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
Up to approximately 63 months
Number of Participants who Discontinue Study Treatment due to an AE
大体时间：Up to approximately 63 months

An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
Up to approximately 63 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
大体时间：Up to approximately 63 months

ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to approximately 63 months

次要结果测量

结果测量
措施说明
大体时间
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
大体时间：Up to approximately 63 months

For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 63 months
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
大体时间：Up to approximately 63 months

PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Up to approximately 63 months
Overall Survival (OS)
大体时间：Up to approximately 63 months

OS is the length of time from when the participant starts treatment until death from any cause
Up to approximately 63 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。

赞助

Merck Sharp & Dohme LLC

调查人员

  • 研究主任：Medical Director、Merck Sharp & Dohme LLC

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。

有用的网址

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6月20日

初级完成 (估计的)

2029年10月16日

研究完成 (估计的)

2029年10月16日

研究注册日期

首次提交

2024年5月20日

首先提交符合 QC 标准的

2024年5月20日

首次发布 (实际的)

2024年5月24日

研究记录更新

最后更新发布 (实际的)

2026年10月29日

上次提交的符合 QC 标准的更新

2026年10月28日

最后验证

2026年10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

  • 9999-02A
  • MK-9999-02A (其他标识符：MSD)
  • U1111-1298-8273 (注册表标识符：UTN)
  • jRCT2031240178 (注册表标识符：jRCT)
  • 2023-508703-21-00 (注册表标识符：EU CT)
  • 2023 (美国 NIH 拨款/合同)

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

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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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