消化器がんの参加者におけるパトリツマブ デルクステカンの研究 (MK-1022-011)
消化器がんにおけるパトリツマブ デルクステカンの安全性と有効性を評価する第 1/2 相試験
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn:
- About the safety and how well people tolerate of patritumab deruxtecan
- How many people have the cancer respond (get smaller or go away) to treatment
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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California
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Santa Monica、California、アメリカ、90404
- UCLA Hematology Oncology Santa Monica ( Site 1205)
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Cancer Center ( Site 1200)
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District of Columbia
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Washington D.C.、District of Columbia、アメリカ、20016
- Sibley Memorial Hospital ( Site 1208)
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Florida
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Gainesville、Florida、アメリカ、32610
- University of Florida ( Site 1202)
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Miami Beach、Florida、アメリカ、33140
- Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
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Georgia
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Marietta、Georgia、アメリカ、30060
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)
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Illinois
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Chicago、Illinois、アメリカ、60637
- University of Chicago Medical Center ( Site 1204)
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Nevada
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Reno、Nevada、アメリカ、89502
- Renown Regional Medical Center ( Site 1221)
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New York
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Mineola、New York、アメリカ、11501
- NYU Langone Hospital - Long Island ( Site 1230)
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New York、New York、アメリカ、10016
- Perlmutter NYU Cancer Center ( Site 1212)
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Texas
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Temple、Texas、アメリカ、76508
- Scott & White Medical Center-Temple ( Site 1224)
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Virginia
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Roanoke、Virginia、アメリカ、24014
- Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin ( Site 1210)
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Haifa、イスラエル、3109601
- Rambam Health Care Campus ( Site 0603)
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Jerusalem、イスラエル、9112001
- Hadassah Medical Center ( Site 0602)
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Tel Aviv、イスラエル、6423906
- Sourasky Medical Center ( Site 0601)
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Milan、イタリア、20133
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
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Milan、イタリア、20162
- ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
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Roma、イタリア、00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
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New South Wales
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Sydney、New South Wales、オーストラリア、2145
- Westmead Hospital ( Site 0100)
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Victoria
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Melbourne、Victoria、オーストラリア、3004
- Alfred Health ( Site 0102)
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Melbourne、Victoria、オーストラリア、3084
- Austin Health ( Site 0103)
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Western Australia
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Mount Pleasant、Western Australia、オーストラリア、6009
- One Clinical Research ( Site 0104)
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H 2Y9
- QEII Health Sciences Centre - Victoria General Site ( Site 0200)
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Ontario
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)
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Quebec
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Montreal、Quebec、カナダ、H4A 3J1
- McGill University Health Centre ( Site 0202)
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Geneva、スイス、1211
- Hopitaux Universitaires de Geneve HUG. ( Site 1102)
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Zurich、スイス、8091
- Universitaetsspital Zuerich ( Site 1105)
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Barcelona、スペイン、08035
- Hospital Universitari Vall d Hebron ( Site 1000)
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Madrid、スペイン、28007
- Hospital Universitario Gregorio Maranon ( Site 1002)
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Madrid、スペイン、28040
- Hospital Clinico San Carlos... ( Site 1003)
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Principality of Asturias
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Oviedo、Principality of Asturias、スペイン、33011
- Hospital Central de Asturias ( Site 1001)
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Bangkok
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Bangkoknoi、Bangkok、タイ、10700
- Faculty of Medicine Siriraj Hospital ( Site 1301)
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Ratchathewi、Bangkok、タイ、10400
- Ramathibodi Hospital ( Site 1302)
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Region M. de Santiago
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Santiago、Region M. de Santiago、チリ、8420383
- Bradfordhill ( Site 0300)
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Santiago、Region M. de Santiago、チリ、7500921
- Fundacion Arturo Lopez Perez ( Site 0301)
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Santiago、Region M. de Santiago、チリ、7560908
- Centro de Oncología de Precisión ( Site 0305)
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Santiago、Region M. de Santiago、チリ、7620002
- Clínica UC San Carlos de Apoquindo ( Site 0302)
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Adana、トルコ（Türkiye）、01370
- Adana City Hospital ( Site 1404)
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Ankara、トルコ（Türkiye）、06230
- Hacettepe Universite Hastaneleri ( Site 1401)
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Ankara
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Yenimahalle、Ankara、トルコ（Türkiye）、06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)
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İzmir
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Balçova、İzmir、トルコ（Türkiye）、35340
- Dokuz Eylul Universitesi Hastanesi ( Site 1402)
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Auckland、ニュージーランド、1023
- Harbour Cancer & Wellness ( Site 0800)
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Auvergne-Rhône-Alpes
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Lyon、Auvergne-Rhône-Alpes、フランス、69004
- Hopital de la Croix Rousse ( Site 0502)
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Hauts-de-Seine
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Clichy、Hauts-de-Seine、フランス、92110
- Hopital Beaujon ( Site 0500)
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Ille-et-Vilaine
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Rennes、Ille-et-Vilaine、フランス、35042
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
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Anhui
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Hefei、Anhui、中国、230088
- The First Affiliated Hospital of Anhui Medical University ( Site 0405)
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Fujian
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Fuzhou、Fujian、中国、350014
- Fujian Provincial Cancer Hospital ( Site 0408)
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Xiamen、Fujian、中国、361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
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Guangdong
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Fuzhou、Guangdong、中国、510515
- Southern Medical University Nanfang Hospital ( Site 0413)
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Guangzhou、Guangdong、中国、510080
- The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)
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Guangxi
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Nanning、Guangxi、中国、530200
- Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
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Henan
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Zhengzhou、Henan、中国、450008
- Henan Cancer Hospital ( Site 0403)
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- Zhongshan Hospital,Fudan University ( Site 0400)
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Shanxi
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Taiyuan、Shanxi、中国、030001
- First Hospital of Shanxi Medical University ( Site 0409)
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Tainan、台湾、704
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
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Taipei、台湾、10002
- National Taiwan University Hospital ( Site 1500)
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Taipei、台湾、112201
- Taipei Veterans General Hospital ( Site 1501)
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Seoul、韓国、03722
- Severance Hospital, Yonsei University Health System ( Site 0903)
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Seoul、韓国、05505
- Asan Medical Center ( Site 0902)
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Seoul、韓国、06351
- Samsung Medical Center ( Site 0901)
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Seoul
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Seodaemun-gu、Seoul、韓国、03080
- Seoul National University Hospital ( Site 0900)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
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Has one of the following cancers:
- Unresectable or metastatic colorectal cancer.
- Advanced and/or unresectable biliary tract cancer (BTC)
- Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
- Locally advanced unresectable or metastatic gastroesophageal cancer
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Has received prior therapy for the cancer.
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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:
- Has a history of (noninfectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
- Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
- Has evidence of any leptomeningeal disease
- Has clinically significant corneal disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Patritumab deruxtecan
Participants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision. |
Administered via intravenous (IV) infusion
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
時間枠：Up to 21 days
|
DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented. |
Up to 21 days
|
|
Number of Participants with One or More Adverse Events (AEs)
時間枠：Up to approximately 44 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. |
Up to approximately 44 months
|
|
Number of Participants who Discontinue Study Intervention Due to an AE
時間枠：Up to approximately 44 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented. |
Up to approximately 44 months
|
|
Objective Response Rate (ORR)
時間枠：Up to approximately 44 months
|
ORR is defined as the percentage of participants with 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 Response Evaluation Criteria in Solid Tumors (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 44 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Duration of Response (DOR)
時間枠：Up to approximately 44 months
|
For participants who demonstrate a 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, 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 44 months
|
|
Progression Free Survival (PFS)
時間枠：Up to approximately 44 months
|
PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per 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. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented. |
Up to approximately 44 months
|
|
Overall Survival (OS)
時間枠：Up to approximately 44 months
|
OS is the length of time from when the participant starts treatment until death from any cause. |
Up to approximately 44 months
|
|
Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
時間枠：At designated time points (up to ~44 months)
|
Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan. |
At designated time points (up to ~44 months)
|
|
Trough Concentration (Ctrough) of Patritumab Deruxtecan
時間枠：At designated time points (up to ~44 months)
|
Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan. |
At designated time points (up to ~44 months)
|
協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1022-011
- MK-1022-011 (その他の識別子：MSD)
- U1111-1305-0677 (レジストリ識別子：UTN)
- 2024-512442-41-00 (レジストリ識別子：EU CT)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。