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

NCT06596694 · tracked via the Priya Life Science USA tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 1/2

Started

2024-11-03

Last updated

2026-08-28

Condition(s) studied

Gastrointestinal Cancer

Investigational drug(s) / intervention(s)

Patritumab deruxtecan

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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	Active Not Recruiting
University of Colorado Cancer Center ( Site 1200)	Aurora	Colorado	Recruiting
Sibley Memorial Hospital ( Site 1208)	Washington D.C.	District of Columbia	Recruiting
University of Florida ( Site 1202)	Gainesville	Florida	Recruiting
Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)	Miami Beach	Florida	Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)	Marietta	Georgia	Completed
University of Chicago Medical Center ( Site 1204)	Chicago	Illinois	Recruiting
Renown Regional Medical Center ( Site 1221)	Reno	Nevada	Active Not Recruiting
NYU Langone Hospital - Long Island ( Site 1230)	Mineola	New York	Completed
Perlmutter NYU Cancer Center ( Site 1212)	New York	New York	Completed
Scott & White Medical Center-Temple ( Site 1224)	Temple	Texas	Completed
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 1207)	Roanoke	Virginia	Recruiting
University of Wisconsin ( Site 1210)	Madison	Wisconsin	Recruiting
Westmead Hospital ( Site 0100)	Sydney	New South Wales	Recruiting
Alfred Health ( Site 0102)	Melbourne	Victoria	Recruiting
Austin Health ( Site 0103)	Melbourne	Victoria	Active Not Recruiting
One Clinical Research ( Site 0104)	Mount Pleasant	Western Australia	Active Not Recruiting
QEII Health Sciences Centre - Victoria General Site ( Site 0200)	Halifax	Nova Scotia	Recruiting
Sunnybrook Research Institute - Odette Cancer Centre ( Site 0206)	Toronto	Ontario	Recruiting
McGill University Health Centre ( Site 0202)	Montreal	Quebec	Recruiting
Fundacion Arturo Lopez Perez ( Site 0301)	Santiago	Region M. de Santiago	Recruiting
Centro de Oncología de Precisión ( Site 0305)	Santiago	Region M. de Santiago	Recruiting
Clínica UC San Carlos de Apoquindo ( Site 0302)	Santiago	Region M. de Santiago	Recruiting
Bradfordhill ( Site 0300)	Santiago	Region M. de Santiago	Recruiting
The First Affiliated Hospital of Anhui Medical University ( Site 0405)	Hefei	Anhui	Recruiting
Fujian Provincial Cancer Hospital ( Site 0408)	Fuzhou	Fujian	Recruiting
Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0412)	Xiamen	Fujian	Recruiting
Southern Medical University Nanfang Hospital ( Site 0413)	Fuzhou	Guangdong	Recruiting
The First Affiliated Hospital, Sun Yat-sen University ( Site 0404)	Guangzhou	Guangdong	Recruiting
Affiliated Cancer Hospital of Guangxi Medical University ( Site 0411)	Nanning	Guangxi	Recruiting
Henan Cancer Hospital ( Site 0403)	Zhengzhou	Henan	Recruiting
Zhongshan Hospital,Fudan University ( Site 0400)	Shanghai	Shanghai Municipality	Recruiting
First Hospital of Shanxi Medical University ( Site 0409)	Taiyuan	Shanxi	Recruiting
Hopital de la Croix Rousse ( Site 0502)	Lyon	Auvergne-Rhône-Alpes	Recruiting
Hopital Beaujon ( Site 0500)	Clichy	Hauts-de-Seine	Recruiting
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0501)	Rennes	Ille-et-Vilaine	Recruiting
Rambam Health Care Campus ( Site 0603)	Haifa	Israel	Recruiting
Hadassah Medical Center ( Site 0602)	Jerusalem	Israel	Recruiting
Sourasky Medical Center ( Site 0601)	Tel Aviv	Israel	Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0700)	Milan	Italy	Recruiting

+ 22 more sites — see the full list on the official registry below.

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Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03) Recruiting

A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002) Recruiting

Other trials for the same condition

A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005) Active, not recruiting

A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors Recruiting

Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring Active, not recruiting

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 the USA