Badanie Patritumabu Deruxtecanu u osób chorych na raka przewodu pokarmowego (MK-1022-011)
Badanie fazy 1/2 oceniające bezpieczeństwo i skuteczność patriumabu deruxtecanu w leczeniu nowotworów przewodu pokarmowego
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
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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New South Wales
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Sydney, New South Wales, Australia, 2145
- Westmead Hospital ( Site 0100)
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Victoria
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Melbourne, Victoria, Australia, 3004
- Alfred Health ( Site 0102)
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Melbourne, Victoria, Australia, 3084
- Austin Health ( Site 0103)
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Western Australia
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Mount Pleasant, Western Australia, Australia, 6009
- One Clinical Research ( Site 0104)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8420383
- Bradfordhill ( Site 0300)
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Santiago, Region M. de Santiago, Chile, 7500921
- Fundacion Arturo Lopez Perez ( Site 0301)
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Santiago, Region M. de Santiago, Chile, 7560908
- Centro de Oncología de Precisión ( Site 0305)
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Santiago, Region M. de Santiago, Chile, 7620002
- Clínica UC San Carlos de Apoquindo ( Site 0302)
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Anhui
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Hefei, Anhui, Chiny, 230088
- The First Affiliated Hospital of Anhui Medical University ( Site 0405)
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Fujian
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Fuzhou, Fujian, Chiny, 350014
- Fujian Provincial Cancer Hospital ( Site 0408)
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Xiamen, Fujian, Chiny, 361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
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Guangdong
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Fuzhou, Guangdong, Chiny, 510515
- Southern Medical University Nanfang Hospital ( Site 0413)
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Guangzhou, Guangdong, Chiny, 510080
- The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)
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Guangxi
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Nanning, Guangxi, Chiny, 530200
- Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
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Henan
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Zhengzhou, Henan, Chiny, 450008
- Henan Cancer Hospital ( Site 0403)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200032
- Zhongshan Hospital,Fudan University ( Site 0400)
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Shanxi
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Taiyuan, Shanxi, Chiny, 030001
- First Hospital of Shanxi Medical University ( Site 0409)
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, Francja, 69004
- Hopital de la Croix Rousse ( Site 0502)
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Hauts-de-Seine
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Clichy, Hauts-de-Seine, Francja, 92110
- Hopital Beaujon ( Site 0500)
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Francja, 35042
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
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Barcelona, Hiszpania, 08035
- Hospital Universitari Vall d Hebron ( Site 1000)
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Madrid, Hiszpania, 28007
- Hospital Universitario Gregorio Maranon ( Site 1002)
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Madrid, Hiszpania, 28040
- Hospital Clinico San Carlos... ( Site 1003)
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Principality of Asturias
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Oviedo, Principality of Asturias, Hiszpania, 33011
- Hospital Central de Asturias ( Site 1001)
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Haifa, Izrael, 3109601
- Rambam Health Care Campus ( Site 0603)
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Jerusalem, Izrael, 9112001
- Hadassah Medical Center ( Site 0602)
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Tel Aviv, Izrael, 6423906
- Sourasky Medical Center ( Site 0601)
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2Y9
- QEII Health Sciences Centre - Victoria General Site ( Site 0200)
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Ontario
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Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)
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Quebec
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Montreal, Quebec, Kanada, H4A 3J1
- McGill University Health Centre ( Site 0202)
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Seoul, Korea Południowa, 03722
- Severance Hospital, Yonsei University Health System ( Site 0903)
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Seoul, Korea Południowa, 05505
- Asan Medical Center ( Site 0902)
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Seoul, Korea Południowa, 06351
- Samsung Medical Center ( Site 0901)
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Seoul
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Seodaemun-gu, Seoul, Korea Południowa, 03080
- Seoul National University Hospital ( Site 0900)
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Auckland, Nowa Zelandia, 1023
- Harbour Cancer & Wellness ( Site 0800)
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California
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Santa Monica, California, Stany Zjednoczone, 90404
- UCLA Hematology Oncology Santa Monica ( Site 1205)
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 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, Stany Zjednoczone, 20016
- Sibley Memorial Hospital ( Site 1208)
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32610
- University of Florida ( Site 1202)
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Miami Beach, Florida, Stany Zjednoczone, 33140
- Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
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Georgia
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Marietta, Georgia, Stany Zjednoczone, 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, Stany Zjednoczone, 60637
- University of Chicago Medical Center ( Site 1204)
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Nevada
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Reno, Nevada, Stany Zjednoczone, 89502
- Renown Regional Medical Center ( Site 1221)
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New York
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Mineola, New York, Stany Zjednoczone, 11501
- NYU Langone Hospital - Long Island ( Site 1230)
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New York, New York, Stany Zjednoczone, 10016
- Perlmutter NYU Cancer Center ( Site 1212)
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Texas
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Temple, Texas, Stany Zjednoczone, 76508
- Scott & White Medical Center-Temple ( Site 1224)
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Virginia
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Roanoke, Virginia, Stany Zjednoczone, 24014
- Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
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Wisconsin
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Madison, Wisconsin, Stany Zjednoczone, 53792
- University of Wisconsin ( Site 1210)
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Geneva, Szwajcaria, 1211
- Hopitaux Universitaires de Geneve HUG. ( Site 1102)
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Zurich, Szwajcaria, 8091
- Universitaetsspital Zuerich ( Site 1105)
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Bangkok
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Bangkoknoi, Bangkok, Tajlandia, 10700
- Faculty of Medicine Siriraj Hospital ( Site 1301)
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Ratchathewi, Bangkok, Tajlandia, 10400
- Ramathibodi Hospital ( Site 1302)
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Tainan, Tajwan, 704
- National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
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Taipei, Tajwan, 10002
- National Taiwan University Hospital ( Site 1500)
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Taipei, Tajwan, 112201
- Taipei Veterans General Hospital ( Site 1501)
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Adana, Turcja (Türkiye), 01370
- Adana City Hospital ( Site 1404)
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Ankara, Turcja (Türkiye), 06230
- Hacettepe Universite Hastaneleri ( Site 1401)
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Ankara
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Yenimahalle, Ankara, Turcja (Türkiye), 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400)
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İzmir
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Balçova, İzmir, Turcja (Türkiye), 35340
- Dokuz Eylul Universitesi Hastanesi ( Site 1402)
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Milan, Włochy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
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Milan, Włochy, 20162
- ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
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Roma, Włochy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Duration of Response (DOR)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1022-011
- MK-1022-011 (Inny identyfikator: MSD)
- U1111-1305-0677 (Identyfikator rejestru: UTN)
- 2024-512442-41-00 (Identyfikator rejestru: EU CT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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