위장암 참가자에 대한 Patritumab Deruxtecan 연구(MK-1022-011)
위장암에 대한 Patritumab Deruxtecan의 안전성과 유효성을 평가하기 위한 1/2상 연구
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
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Auckland, 뉴질랜드, 1023
- Harbour Cancer & Wellness ( Site 0800)
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Tainan, 대만, 704
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
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Taipei, 대만, 10002
- National Taiwan University Hospital ( Site 1500)
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Taipei, 대만, 112201
- Taipei Veterans General Hospital ( Site 1501)
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Seoul, 대한민국, 03722
- Severance Hospital, Yonsei University Health System ( Site 0903)
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Seoul, 대한민국, 05505
- Asan Medical Center ( Site 0902)
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Seoul, 대한민국, 06351
- Samsung Medical Center ( Site 0901)
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Seoul
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Seodaemun-gu, Seoul, 대한민국, 03080
- Seoul National University Hospital ( Site 0900)
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California
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Santa Monica, California, 미국, 90404
- UCLA Hematology Oncology Santa Monica ( Site 1205)
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Colorado
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Aurora, Colorado, 미국, 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, 미국, 20016
- Sibley Memorial Hospital ( Site 1208)
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Florida
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Gainesville, Florida, 미국, 32610
- University of Florida ( Site 1202)
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Miami Beach, Florida, 미국, 33140
- Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
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Georgia
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Marietta, Georgia, 미국, 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, 미국, 60637
- University of Chicago Medical Center ( Site 1204)
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Nevada
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Reno, Nevada, 미국, 89502
- Renown Regional Medical Center ( Site 1221)
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New York
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Mineola, New York, 미국, 11501
- NYU Langone Hospital - Long Island ( Site 1230)
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New York, New York, 미국, 10016
- Perlmutter NYU Cancer Center ( Site 1212)
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Texas
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Temple, Texas, 미국, 76508
- Scott & White Medical Center-Temple ( Site 1224)
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Virginia
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Roanoke, Virginia, 미국, 24014
- Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin ( Site 1210)
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Geneva, 스위스, 1211
- Hopitaux Universitaires de Geneve HUG. ( Site 1102)
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Zurich, 스위스, 8091
- Universitaetsspital Zuerich ( Site 1105)
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d Hebron ( Site 1000)
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Madrid, 스페인, 28007
- Hospital Universitario Gregorio Maranon ( Site 1002)
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos... ( Site 1003)
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Principality of Asturias
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Oviedo, Principality of Asturias, 스페인, 33011
- Hospital Central de Asturias ( Site 1001)
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Haifa, 이스라엘, 3109601
- Rambam Health Care Campus ( Site 0603)
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Jerusalem, 이스라엘, 9112001
- Hadassah Medical Center ( Site 0602)
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Tel Aviv, 이스라엘, 6423906
- Sourasky Medical Center ( Site 0601)
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Milan, 이탈리아, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
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Milan, 이탈리아, 20162
- ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
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Roma, 이탈리아, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
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Anhui
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Hefei, Anhui, 중국, 230088
- The First Affiliated Hospital of Anhui Medical University ( Site 0405)
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Fujian
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Fuzhou, Fujian, 중국, 350014
- Fujian Provincial Cancer Hospital ( Site 0408)
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Xiamen, Fujian, 중국, 361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
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Guangdong
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Fuzhou, Guangdong, 중국, 510515
- Southern Medical University Nanfang Hospital ( Site 0413)
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Guangzhou, Guangdong, 중국, 510080
- The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)
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Guangxi
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Nanning, Guangxi, 중국, 530200
- Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
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Henan
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Zhengzhou, Henan, 중국, 450008
- Henan Cancer Hospital ( Site 0403)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200032
- Zhongshan Hospital,Fudan University ( Site 0400)
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Shanxi
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Taiyuan, Shanxi, 중국, 030001
- First Hospital of Shanxi Medical University ( Site 0409)
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Region M. de Santiago
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Santiago, Region M. de Santiago, 칠레, 8420383
- Bradfordhill ( Site 0300)
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Santiago, Region M. de Santiago, 칠레, 7500921
- Fundacion Arturo Lopez Perez ( Site 0301)
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Santiago, Region M. de Santiago, 칠레, 7560908
- Centro de Oncología de Precisión ( Site 0305)
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Santiago, Region M. de Santiago, 칠레, 7620002
- Clínica UC San Carlos de Apoquindo ( Site 0302)
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 2Y9
- QEII Health Sciences Centre - Victoria General Site ( Site 0200)
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Ontario
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)
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Quebec
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Montreal, Quebec, 캐나다, H4A 3J1
- McGill University Health Centre ( Site 0202)
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Bangkok
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Bangkoknoi, Bangkok, 태국, 10700
- Faculty of Medicine Siriraj Hospital ( Site 1301)
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Ratchathewi, Bangkok, 태국, 10400
- Ramathibodi Hospital ( Site 1302)
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Adana, 터키 (Türkiye), 01370
- Adana City Hospital ( Site 1404)
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Ankara, 터키 (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 1401)
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Ankara
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Yenimahalle, Ankara, 터키 (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)
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İzmir
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Balçova, İzmir, 터키 (Türkiye), 35340
- Dokuz Eylul Universitesi Hastanesi ( Site 1402)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, 프랑스, 69004
- Hopital de la Croix Rousse ( Site 0502)
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Hauts-de-Seine
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Clichy, Hauts-de-Seine, 프랑스, 92110
- Hopital Beaujon ( Site 0500)
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, 프랑스, 35042
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
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New South Wales
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Sydney, New South Wales, 호주, 2145
- Westmead Hospital ( Site 0100)
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Victoria
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Melbourne, Victoria, 호주, 3004
- Alfred Health ( Site 0102)
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Melbourne, Victoria, 호주, 3084
- Austin Health ( Site 0103)
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Western Australia
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Mount Pleasant, Western Australia, 호주, 6009
- One Clinical Research ( Site 0104)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
기간: Up to 21 days
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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
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Number of Participants with One or More Adverse Events (AEs)
기간: Up to approximately 44 months
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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
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Number of Participants who Discontinue Study Intervention Due to an AE
기간: Up to approximately 44 months
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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
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Objective Response Rate (ORR)
기간: Up to approximately 44 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of Response (DOR)
기간: Up to approximately 44 months
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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
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Progression Free Survival (PFS)
기간: Up to approximately 44 months
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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
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Overall Survival (OS)
기간: Up to approximately 44 months
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OS is the length of time from when the participant starts treatment until death from any cause. |
Up to approximately 44 months
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Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
기간: At designated time points (up to ~44 months)
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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)
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Trough Concentration (Ctrough) of Patritumab Deruxtecan
기간: At designated time points (up to ~44 months)
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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)
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공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1022-011
- MK-1022-011 (기타 식별자: MSD)
- U1111-1305-0677 (레지스트리 식별자: UTN)
- 2024-512442-41-00 (레지스트리 식별자: EU CT)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .