Clinical trial NCT06864169: A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
Official title: A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2025-03-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Approximately 15 months
Secondary outcomes:
measure: Number of Participants who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 14 months
measure: Number of Participants who Discontinue Study Treatment due to an AE
timeFrame: Up to approximately 12 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 49 months
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 49 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 49 months
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mt Sinai Comprehensive Cancer Center ( Site 0345)
state: Florida
city: Billings
country: United States
facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0347)
state: Montana
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 0369)
state: Ohio
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center ( Site 0348)
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Nefra Medical Care - CEMIC Saavedra ( Site 0008)
state: Caba
city: Rosario.
country: Argentina
facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)
state: Santa Fe
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006)
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0044)
state: Ontario
city: Santiago.
country: Chile
facility: FALP ( Site 0062)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA ( Site 0064)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica UC San Carlos de Apoquindo ( Site 0066)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0069)
state: Region M. De Santiago
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0081)
state: Val-de-Marne
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital ( Site 0122)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 0121)
city: Badalona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Badalona ( Site 0222)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla ( Site 0221)
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona ( Site 0223)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón ( Site 0225)
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0261)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 0266)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 0262)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: