Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

Официальное название

A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

Обзор

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

Вмешательства

• Биопрепарат Patritumab deruxtecan
  Administered via intravenous (IV) infusion

Первичные конечные точки

• Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase) [Срок оценки: Up to 21 days]
• Number of Participants with One or More Adverse Events (AEs) [Срок оценки: Up to approximately 44 months]
• Number of Participants who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 44 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 44 months]

Вторичные конечные точки (5)

• Duration of Response (DOR) [Срок оценки: Up to approximately 44 months]
• Progression Free Survival (PFS) [Срок оценки: Up to approximately 44 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 44 months]
• Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan [Срок оценки: At designated time points (up to ~44 months)]
• Trough Concentration (Ctrough) of Patritumab Deruxtecan [Срок оценки: At designated time points (up to ~44 months)]

Критерии участия

Критерии включения

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

• 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
• Has received prior therapy for the cancer.
• Has recovered from any side effects due to previous cancer treatment

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 13 центров

• UCLA Hematology Oncology Santa Monica ( Site 1205) — Santa Monica
• University of Colorado Cancer Center ( Site 1200) — Aurora
• Sibley Memorial Hospital ( Site 1208) — Washington D.C.
• University of Florida ( Site 1202) — Gainesville
• Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213) — Miami Beach
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 12 — Marietta
• University of Chicago Medical Center ( Site 1204) — Chicago
• Renown Regional Medical Center ( Site 1221) — Reno
• … и ещё 5 центров

Китай · 9 центров

• The First Affiliated Hospital of Anhui Medical University ( Site 0405) — Хэфэй
• Fujian Provincial Cancer Hospital ( Site 0408) — Фучжоу
• Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412) — Xiamen
• Southern Medical University Nanfang Hospital ( Site 0413) — Фучжоу
• The First Affiliated Hospital, Sun Yat-sen University ( Site 0404) — Гуанчжоу
• Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411) — Nanning
• Henan Cancer Hospital ( Site 0403) — Чжэнчжоу
• Zhongshan Hospital,Fudan University ( Site 0400) — Шанхай
• … и ещё 1 центр

Австралия · 4 центра

• Westmead Hospital ( Site 0100) — Sydney
• Alfred Health ( Site 0102) — Melbourne
• Austin Health ( Site 0103) — Melbourne
• One Clinical Research ( Site 0104) — Mount Pleasant

Чили · 4 центра

• Fundacion Arturo Lopez Perez ( Site 0301) — Santiago
• Centro de Oncología de Precisión ( Site 0305) — Santiago
• Clínica UC San Carlos de Apoquindo ( Site 0302) — Santiago
• Bradfordhill ( Site 0300) — Santiago

South Korea · 4 центра

• Seoul National University Hospital ( Site 0900) — Seodaemun-gu
• Severance Hospital, Yonsei University Health System ( Site 0903) — Seoul
• Asan Medical Center ( Site 0902) — Seoul
• Samsung Medical Center ( Site 0901) — Seoul

Испания · 4 центра

• Hospital Central de Asturias ( Site 1001) — Oviedo
• Hospital Universitari Vall d'Hebron ( Site 1000) — Barcelona
• Hospital Universitario Gregorio Maranon ( Site 1002) — Madrid
• Hospital Clinico San Carlos... ( Site 1003) — Madrid

Turkey (Türkiye) · 4 центра

• Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi ( Site 1400) — Yenimahalle
• Dokuz Eylul Universitesi Hastanesi ( Site 1402) — Balçova
• Adana City Hospital ( Site 1404) — Adana
• Hacettepe Universite Hastaneleri ( Site 1401) — Ankara

Канада · 3 центра

• QEII Health Sciences Centre - Victoria General Site ( Site 0200) — Halifax
• Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206) — Toronto
• McGill University Health Centre ( Site 0202) — Montreal

Франция · 3 центра

• Hopital de la Croix Rousse ( Site 0502) — Lyon
• Hopital Beaujon ( Site 0500) — Clichy
• Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501) — Rennes

Израиль · 3 центра

• Rambam Health Care Campus ( Site 0603) — Haifa
• Hadassah Medical Center ( Site 0602) — Jerusalem
• Sourasky Medical Center ( Site 0601) — Tel Aviv

Италия · 3 центра

• Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700) — Milan
• ASST Grande Ospedale Metropolitano Niguarda ( Site 0701) — Milan
• Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702) — Roma

Тайвань · 3 центра

• National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502) — Tainan
• National Taiwan University Hospital ( Site 1500) — Taipei
• Taipei Veterans General Hospital ( Site 1501) — Taipei

Швейцария · 2 центра

• Hopitaux Universitaires de Geneve HUG. ( Site 1102) — Geneva
• Universitaetsspital Zuerich ( Site 1105) — Zurich

Таиланд · 2 центра

• Faculty of Medicine Siriraj Hospital ( Site 1301) — Bangkoknoi
• Ramathibodi Hospital ( Site 1302) — Ratchathewi

Новая Зеландия · 1 центр

• Harbour Cancer & Wellness ( Site 0800) — Auckland

Идентификаторы

NCT: NCT06596694 · 1022-011 · MK-1022-011 · 2024-512442-41-00 · U1111-1305-0677

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗