Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
- Registration Number
- NCT06596694
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patritumab deruxtecan 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.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase) 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.
Number of Participants with One or More Adverse Events (AEs) Up to approximately 45 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.
Number of Participants who Discontinue Study Intervention Due to an AE Up to approximately 45 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.
Objective Response Rate (ORR) Up to approximately 45 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.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to approximately 45 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.
Progression Free Survival (PFS) Up to approximately 45 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.
Overall Survival (OS) Up to approximately 45 months OS is the length of time from when the participant starts treatment until death from any cause.
Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan At designated time points (up to ~45 months) Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan.
Trough Concentration (Ctrough) of Patritumab Deruxtecan At designated time points (up to ~45 months) Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan.
Trial Locations
- Locations (52)
Alfred Health ( Site 0102)
🇦🇺Melbourne, Victoria, Australia
Austin Health ( Site 0103)
🇦🇺Melbourne, Victoria, Australia
One Clinical Research ( Site 0104)
🇦🇺Mount Pleasant, Western Australia, Australia
QEII Health Sciences Centre - Victoria General Site ( Site 0200)
🇨🇦Halifax, Nova Scotia, Canada
Fundacion Arturo Lopez Perez ( Site 0301)
🇨🇱Santiago., Region M. De Santiago, Chile
Centro de Oncología de Precisión ( Site 0305)
🇨🇱Santiago, Region M. De Santiago, Chile
Clínica UC San Carlos de Apoquindo ( Site 0302)
🇨🇱Santiago, Region M. De Santiago, Chile
Bradfordhill ( Site 0300)
🇨🇱Santiago, Region M. De Santiago, Chile
The First Affiliated Hospital of Anhui Medical University ( Site 0405)
🇨🇳Hefei, Anhui, China
Fujian Provincial Cancer Hospital ( Site 0408)
🇨🇳Fuzhou, Fujian, China
Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)
🇨🇳Xiamen, Fujian, China
Southern Medical University Nanfang Hospital ( Site 0413)
🇨🇳Fuzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)
🇨🇳Nanning, Guangxi, China
Hopital de la Croix Rousse ( Site 0502)
🇫🇷Lyon, Rhone-Alpes, France
Henan Cancer Hospital ( Site 0403)
🇨🇳Zhengzhou, Henan, China
Zhongshan Hospital,Fudan University ( Site 0400)
🇨🇳Shanghai, Shanghai, China
First Hospital of Shanxi Medical University ( Site 0409)
🇨🇳Tai Yuan, Shanxi, China
Hopital Beaujon ( Site 0500)
🇫🇷Clichy, Hauts-de-Seine, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)
🇫🇷Rennes, Ille-et-Vilaine, France
Rambam Health Care Campus ( Site 0603)
🇮🇱Haifa, Israel
Sourasky Medical Center ( Site 0601)
🇮🇱Tel Aviv, Israel
Hadassah Medical Center ( Site 0602)
🇮🇱Yerushalayim, Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)
🇮🇹Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0701)
🇮🇹Milano, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0702)
🇮🇹Roma, Italy
Seoul National University Hospital ( Site 0900)
🇰🇷Seodaemun-gu, Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System ( Site 0903)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center ( Site 0902)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 0901)
🇰🇷Seoul, Korea, Republic of
Harbour Cancer & Wellness ( Site 0800)
🇳🇿Auckland, New Zealand
Hospital Central de Asturias ( Site 1001)
🇪🇸Oviedo, Asturias, Spain
Hospital Universitari Vall d'Hebron ( Site 1000)
🇪🇸Barcelona, Spain
Hospital Universitario Gregorio Maranon ( Site 1002)
🇪🇸Madrid, Spain
Hospital Clinico San Carlos... ( Site 1003)
🇪🇸Madrid, Spain
Hopitaux Universitaires de Geneve HUG. ( Site 1102)
🇨🇭Geneve, Switzerland
Universitaetsspital Zuerich ( Site 1105)
🇨🇭Zurich, Switzerland
National Cheng Kung University Hospital-Clinical Trial Center ( Site 1502)
🇨🇳Tainan, Taiwan
National Taiwan University Hospital ( Site 1500)
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital ( Site 1501)
🇨🇳Taipei, Taiwan
Faculty of Medicine Siriraj Hospital ( Site 1301)
🇹🇭Bangkoknoi, Krung Thep Maha Nakhon, Thailand
Ramathibodi Hospital ( Site 1302)
🇹🇭Ratchathewi, Krung Thep Maha Nakhon, Thailand
Hacettepe Universite Hastaneleri ( Site 1401)
🇹🇷Ankara, Turkey
UCLA Hematology Oncology Santa Monica ( Site 1205)
🇺🇸Santa Monica, California, United States
Sibley Memorial Hospital ( Site 1208)
🇺🇸Washington, District of Columbia, United States
University of Florida ( Site 1202)
🇺🇸Gainesville, Florida, United States
Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
🇺🇸Miami Beach, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)
🇺🇸Marietta, Georgia, United States
Renown Regional Medical Center ( Site 1221)
🇺🇸Reno, Nevada, United States
Perlmutter NYU Cancer Center ( Site 1212)
🇺🇸New York, New York, United States
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)
🇺🇸Roanoke, Virginia, United States
University of Wisconsin ( Site 1210)
🇺🇸Madison, Wisconsin, United States
Westmead Hospital ( Site 0100)
🇦🇺Sydney, New South Wales, Australia