Clinical trial NCT06596694: Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
Official title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2024-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.
  * Advanced and/or unresectable biliary tract cancer (BTC)
  * Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
* Has received prior therapy for the 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:

* Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis, and/or suspected ILD/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

Primary outcomes:
measure: Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
timeFrame: Up to 21 days
measure: Number of Participants with One or More Adverse Events (AEs)
timeFrame: Up to approximately 45 months
measure: Number of Participants who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 45 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 45 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to approximately 45 months
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 45 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 45 months
measure: Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
timeFrame: At designated time points (up to ~45 months)
measure: Trough Concentration (Ctrough) of Patritumab Deruxtecan
timeFrame: At designated time points (up to ~45 months)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology Santa Monica ( Site 1205)
state: California
city: Washington
country: United States
facility: Sibley Memorial Hospital ( Site 1208)
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida ( Site 1202)
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center ( Site 1204)
state: Illinois
city: Reno
country: United States
facility: Renown Regional Medical Center ( Site 1221)
state: Nevada
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island ( Site 1230)
state: New York
city: New York
country: United States
facility: Perlmutter NYU Cancer Center ( Site 1212)
state: New York
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin ( Site 1210)
state: Wisconsin
city: Sydney
country: Australia
facility: Westmead Hospital ( Site 0100)
state: New South Wales
city: Melbourne
country: Australia
facility: Alfred Health ( Site 0102)
state: Victoria
city: Melbourne
country: Australia
facility: Austin Health ( Site 0103)
state: Victoria
city: Mount Pleasant
country: Australia
facility: One Clinical Research ( Site 0104)
state: Western Australia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Victoria General Site ( Site 0200)
state: Nova Scotia
city: Santiago.
country: Chile
facility: Fundacion Arturo Lopez Perez ( Site 0301)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Oncología de Precisión ( Site 0305)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica UC San Carlos de Apoquindo ( Site 0302)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0300)
state: Region M. De Santiago
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University ( Site 0405)
state: Anhui
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 0408)
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
state: Fujian
city: Fuzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 0413)
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
state: Guangxi
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 0403)
state: Henan
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University ( Site 0400)
state: Shanghai
city: Tai Yuan
country: China
facility: First Hospital of Shanxi Medical University ( Site 0409)
state: Shanxi
city: Clichy
country: France
facility: Hopital Beaujon ( Site 0500)
state: Hauts-de-Seine
city: Rennes
country: France
facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
state: Ille-et-Vilaine
city: Lyon
country: France
facility: Hopital de la Croix Rousse ( Site 0502)
state: Rhone-Alpes
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0603)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0601)
city: Yerushalayim
country: Israel
facility: Hadassah Medical Center ( Site 0602)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
city: Seodaemun-gu
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0900)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 0903)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 0902)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0901)
city: Auckland
country: New Zealand
facility: Harbour Cancer & Wellness ( Site 0800)
city: Oviedo
country: Spain
facility: Hospital Central de Asturias ( Site 1001)
state: Asturias
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron ( Site 1000)
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon ( Site 1002)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos... ( Site 1003)
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG. ( Site 1102)
city: Zurich
country: Switzerland
facility: Universitaetsspital Zuerich ( Site 1105)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1500)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1501)
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 1301)
state: Krung Thep Maha Nakhon
city: Ratchathewi
country: Thailand
facility: Ramathibodi Hospital ( Site 1302)
state: Krung Thep Maha Nakhon
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri ( Site 1401)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: