Clinical Trials - DataSource by Daiichi Sankyo

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

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

PRODUCT

R-DXd

GENDER

ALL

AGE

18 Years

SPONSOR

Merck Sharp & Dohme LLC

COLLABORATOR

Daiichi Sankyo

TRIAL RUNS IN

41 Global Locations

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

The main inclusion criteria include but are not limited to the following:
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)

The main exclusion criteria include but are not limited to the following:
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

This was last updated on 2025-11-06 19:34:19.533.

The content contained is taken is taken directly from public registry ClinicalTrials.gov and has not been edited.

Information about pipeline compounds or investigational uses of compounds does not imply FDA approval for these compounds or uses, nor does it establish the safety or efficacy of these compounds or uses. There is no guarantee that the pipeline compounds or investigational uses will receive FDA approval. Daiichi Sankyo does not recommend or suggest use of its medicines in a manner inconsistent with FDA-approved labeling.