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Clinical Trials List

Protocol NumberMK-5909-005
NCT Number(ClinicalTrials.gov Identfier)NCT06864169
Active

2025-01-10 - 2031-05-31

Phase II

Recruiting6

ICD-10C26.9

Malignant neoplasm of ill-defined sites within the digestive system

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9159.9

Malignant neoplasm of ill-defined sites within the digestive organs and peritoneum

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

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇迺文 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gastrointestinal Cancer

Objectives

Primary Objective: Assess the objective response rate (ORR) confirmed by blinded independent central review (BICR) according to the RECIST 1.1 criteria for response to solid tumors, version 1.1. Secondary Objectives: Assess the safety and tolerability of R-DXd Assess the duration of response (DOR) as assessed by BICR according to RECIST 1.1 Assess progression-free survival (PFS) as assessed by BICR according to RECIST 1.1 Assess overall survival (OS)

Test Drug

注射劑

Active Ingredient

MK-5909

Dosage Form

270

Dosage

100mg/vial

Endpoints

Objective response: Complete response (CR) or partial response (PR)

Inclution 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

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

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    160 participants

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