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

Launched by MERCK SHARP & DOHME LLC · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called raludotatug deruxtecan (often shortened to R-DXd) for people with advanced gastrointestinal (GI) cancers, such as pancreatic, colorectal, or gastric cancers. The goal of the study is to see if this medication can help shrink tumors or even eliminate them. R-DXd works by attaching to cancer cells and delivering a special treatment directly to them, which may help destroy the cancer.

To participate in this study, patients should be between the ages of 65 and 74 and must have certain types of advanced GI cancers that cannot be surgically removed. They should have already received prior treatment for their cancer and have at least three months of life expectancy. Participants will be monitored closely throughout the trial to see how their cancer responds to the treatment. It's important to note that some people may not be eligible if they have a history of certain lung or heart issues, or if they have other active cancers or serious autoimmune diseases. If you or a loved one is considering this trial, it could be an opportunity to try a new treatment option for difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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)
• Exclusion Criteria:
• 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