RECRUITING

A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)

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 are looking for new ways to treat certain types of advanced gastrointestinal (GI) cancers. The study medicine raludotatug deruxtecan (also called MK-5909, R-DXd, or DS-6000a) is a type of medicine called an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goal of this study is to learn if the cancer responds to treatment (gets smaller or goes away).

Official Title

A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers

Quick Facts

Study Start:2025-04-09
Study Completion:2029-05-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06864169

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 pancreatic ductal adenocarcinoma (PDAC)
  3. * Unresectable or metastatic adenocarcinoma of the biliary tract \[intra- or extrahepatic holangiocarcinoma (CCA) or gallbladder cancer (GBC)\]
  4. * Unresectable or metastatic colorectal adenocarcinoma
  5. * Unresectable or metastatic gastric adenocarcinoma
  6. * Gastroesophageal junction adenocarcinoma (GEJAC)
  7. * Esophageal adenocarcinoma (EAC)
  8. * Has received prior therapy for the cancer
  9. * Has a life expectancy of at least 3 months
  10. * If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)
  1. * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis
  2. * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  3. * Has uncontrolled or significant cardiovascular disease
  4. * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  5. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  6. * Active autoimmune disease that has required systemic treatment in the past 2 years
  7. * Has not adequately recovered from major surgery or has ongoing surgical complications
  8. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's 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)

Mt Sinai Comprehensive Cancer Center ( Site 0345)
Miami Beach, Florida, 33140
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 Date2025-04-09
Study Completion Date2029-05-06

Study Record Updates

Study Start Date2025-04-09
Study Completion Date2029-05-06

Terms related to this study

Additional Relevant MeSH Terms

  • Gastrointestinal Cancer