RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-03
Study Completion:2028-07-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06596694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has one of the following cancers:
  2. * Unresectable or metastatic colorectal cancer
  3. * Advanced and/or unresectable biliary tract cancer (BTC)
  4. * Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
  5. * Has received prior therapy for the cancer
  6. * Has recovered from any side effects due to previous cancer treatment
  1. * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
  2. * Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
  3. * Has clinically significant corneal disease
  4. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213)
Miami Beach, Florida, 33140
United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203)
Marietta, Georgia, 30060
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-03
Study Completion Date2028-07-24

Study Record Updates

Study Start Date2024-11-03
Study Completion Date2028-07-24

Terms related to this study

Additional Relevant MeSH Terms

  • Gastrointestinal Cancer