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

Phase 2

Recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Biological: Raludotatug Deruxtecan (R-DXd)

• Registration Number: NCT06864169
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-07-06
• Study Completion: 2029-05-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Raludotatug Deruxtecan (R-DXd)	Raludotatug Deruxtecan (R-DXd)	R-DXd will be administered via IV infusion.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Approximately 15 months	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

Secondary Outcome Measures

Name	Time	Method
Number of Participants who Experience One or More Adverse Events (AEs)	Up to approximately 14 months	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants who Discontinue Study Treatment due to an AE	Up to approximately 12 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Duration of Response (DOR)	Up to approximately 49 months	For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Progression Free Survival (PFS)	Up to approximately 49 months	PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Overall Survival (OS)	Up to approximately 49 months	OS is defined as the time from the first dose to death due to any cause.

Trial Locations

Locations (16)

St. Vincent Healthcare Frontier Cancer Center ( Site 0347); 🇺🇸 Billings, Montana, United States

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006); 🇦🇷 La Rioja, Argentina

FALP ( Site 0062); 🇨🇱 Santiago., Region M. De Santiago, Chile

Centro de Estudios Clínicos SAGA ( Site 0064); 🇨🇱 Santiago, Region M. De Santiago, Chile

Clínica UC San Carlos de Apoquindo ( Site 0066); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill ( Site 0069); 🇨🇱 Santiago, Region M. De Santiago, Chile

Mt Sinai Comprehensive Cancer Center ( Site 0345); 🇺🇸 Miami Beach, Florida, United States

University of Wisconsin Carbone Cancer Center ( Site 0348); 🇺🇸 Madison, Wisconsin, United States

Gustave Roussy ( Site 0081); 🇫🇷 Villejuif, Val-de-Marne, France

Prince of Wales Hospital ( Site 0122); 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital ( Site 0121); 🇭🇰 Hong Kong, Hong Kong

Institut Català d'Oncologia (ICO) - Badalona ( Site 0222); 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla ( Site 0221); 🇪🇸 Santander, Cantabria, Spain

Hospital Clinic de Barcelona ( Site 0223); 🇪🇸 Barcelona, Spain

Hospital General Universitario Gregorio Marañón ( Site 0225); 🇪🇸 Madrid, Spain

Mackay Memorial Hospital ( Site 0266); 🇨🇳 Taipei, Taiwan