TITRE (EN) A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers
PROTOCOLE ID MK-5909-005 (REJOICE-GI01)
CLINICAL TRIAL.gov ID NCT06864169
TYPE(S) DE CANCER Oesophage
PHASE Phase II
TYPE D'ÉTUDE Clinique
INSTITUTION CHUM
1051 rue Sanguinet
(514) 890-8000
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Francine Aubin
COORDONATEUR(RICE) Adeline Hamon
parc.eligibilite.chum@ssss.gouv.qc.ca
514-890-8000 poste 30737
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

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)
CRITÈRES D'EXCLUSION (EN)

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