Clinical Trials in South Korea / NCT06596694
Active, not recruiting
Phase 1/2
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
NCT06596694 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Gastrointestinal Cancer
Investigational drug(s) / intervention(s)
Patritumab deruxtecan: Administered via intravenous (IV) infusion
Study 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
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
* 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
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
Primary outcome measure(s)
- 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 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. - Number of Participants who Discontinue Study Intervention Due to an AE — 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. - Objective Response Rate (ORR) — 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.
Trial sites (62)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLA Hematology Oncology Santa Monica ( Site 1205) | Santa Monica | California | |
| University of Colorado Cancer Center ( Site 1200) | Aurora | Colorado | |
| Sibley Memorial Hospital ( Site 1208) | Washington D.C. | District of Columbia | |
| University of Florida ( Site 1202) | Gainesville | Florida | |
| Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213) | Miami Beach | Florida | |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203) | Marietta | Georgia | |
| University of Chicago Medical Center ( Site 1204) | Chicago | Illinois | |
| Renown Regional Medical Center ( Site 1221) | Reno | Nevada | |
| NYU Langone Hospital - Long Island ( Site 1230) | Mineola | New York | |
| Perlmutter NYU Cancer Center ( Site 1212) | New York | New York | |
| Scott & White Medical Center-Temple ( Site 1224) | Temple | Texas | |
| Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207) | Roanoke | Virginia | |
| University of Wisconsin ( Site 1210) | Madison | Wisconsin | |
| Westmead Hospital ( Site 0100) | Sydney | New South Wales | |
| Alfred Health ( Site 0102) | Melbourne | Victoria | |
| Austin Health ( Site 0103) | Melbourne | Victoria | |
| One Clinical Research ( Site 0104) | Mount Pleasant | Western Australia | |
| QEII Health Sciences Centre - Victoria General Site ( Site 0200) | Halifax | Nova Scotia | |
| Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206) | Toronto | Ontario | |
| McGill University Health Centre ( Site 0202) | Montreal | Quebec | |
| Fundacion Arturo Lopez Perez ( Site 0301) | Santiago | Region M. de Santiago | |
| Centro de Oncología de Precisión ( Site 0305) | Santiago | Region M. de Santiago | |
| Clínica UC San Carlos de Apoquindo ( Site 0302) | Santiago | Region M. de Santiago | |
| Bradfordhill ( Site 0300) | Santiago | Region M. de Santiago | |
| The First Affiliated Hospital of Anhui Medical University ( Site 0405) | Hefei | Anhui | |
| Fujian Provincial Cancer Hospital ( Site 0408) | Fuzhou | Fujian | |
| Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412) | Xiamen | Fujian | |
| Southern Medical University Nanfang Hospital ( Site 0413) | Fuzhou | Guangdong | |
| The First Affiliated Hospital, Sun Yat-sen University ( Site 0404) | Guangzhou | Guangdong | |
| Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411) | Nanning | Guangxi | |
| Henan Cancer Hospital ( Site 0403) | Zhengzhou | Henan | |
| Zhongshan Hospital,Fudan University ( Site 0400) | Shanghai | Shanghai Municipality | |
| First Hospital of Shanxi Medical University ( Site 0409) | Taiyuan | Shanxi | |
| Hopital de la Croix Rousse ( Site 0502) | Lyon | Auvergne-Rhône-Alpes | |
| Hopital Beaujon ( Site 0500) | Clichy | Hauts-de-Seine | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501) | Rennes | Ille-et-Vilaine | |
| Rambam Health Care Campus ( Site 0603) | Haifa | Israel | |
| Hadassah Medical Center ( Site 0602) | Jerusalem | Israel | |
| Sourasky Medical Center ( Site 0601) | Tel Aviv | Israel | |
| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700) | Milan | Italy |
+ 22 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in South Korea
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06596694 on ClinicalTrials.gov ↗ ← All trials in South Korea