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

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).

Conditions

Gastrointestinal Cancer

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Gastrointestinal Cancer
Intervention / Treatment

-

Contacts and Locations

Miami Beach

Mt Sinai Comprehensive Cancer Center ( Site 0345), Miami Beach, Florida, United States, 33140

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2029-05-06