Study on Raludotatug Deruxtecan (R-DXd) for People with Advanced Gastrointestinal Cancers

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT06864169

This clinical trial is testing a new treatment called raludotatug deruxtecan (R-DXd) to see if it can help shrink or eliminate certain advanced gastrointestinal cancers. The treatment works by targeting cancer cells and delivering medication directly to them.

Patient Parameters

Program Overview

Researchers are exploring a new treatment option for advanced gastrointestinal cancers using a medicine called raludotatug deruxtecan (R-DXd). This medicine is an antibody-drug conjugate (ADC), which means it attaches to a specific protein on cancer cells and delivers a drug to help destroy them. The main aim of the study is to find out if this treatment can make the cancer smaller or make it go away.

Eligibility Criteria

Inclusion Criteria

  • Have one of the following types of cancer that cannot be removed by surgery or has spread:
    • Pancreatic ductal adenocarcinoma
    • Biliary tract adenocarcinoma, including cholangiocarcinoma or gallbladder cancer
    • Colorectal adenocarcinoma
    • Gastric adenocarcinoma
    • Gastroesophageal junction adenocarcinoma
    • Esophageal adenocarcinoma
  • Have received previous treatment for the cancer
  • Have a life expectancy of at least 3 months
  • If living with HIV, must have the virus well controlled with medication

Exclusion Criteria

  • Have a history of lung disease that required steroids or currently have lung issues
  • Have severe lung problems due to other illnesses
  • Have uncontrolled or serious heart disease
  • Have another cancer that is getting worse or needed treatment in the last 3 years
  • Have cancer that has spread to the brain or spinal cord
  • Have an active autoimmune disease that needed treatment in the last 2 years
  • Have not fully recovered from major surgery or have ongoing surgery-related issues
  • If living with HIV, have a history of Kaposi's sarcoma or Multicentric Castleman's Disease

Locations

FACILITYZIPCITYSTATE
Mt Sinai Comprehensive Cancer Center ( Site 0345)33140Miami BeachFlorida
St. Vincent Healthcare Frontier Cancer Center ( Site 0347)59102BillingsMontana
University of Wisconsin Carbone Cancer Center ( Site 0348)53792MadisonWisconsin

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