Tumeurs solides

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TITRE Étude multicentrique ouverte de phase II visant à évaluer l’efficacité et l’innocuité du trastuzumab déruxtécan (T-DXd, DS-8201a) dans le traitement de certaines tumeurs exprimant HER2
PROTOCOLE ID DESTINY-PanTumor02
CLINICAL TRIAL.gov ID NCT04482309
TYPE(S) DE CANCER Tumeurs solides
PHASE Phase II
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Olivier Dumas
COORDONATEUR(RICE) Marie-Pierre Brochu
marie-pierre.brochu@mail.chudequebec.ca
418-525-4444 poste 15768
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Locally advanced, unresectable, or metastatic disease based on most recent imaging.

  • The respective cohorts for patient inclusion are:

    • Cohort 1: Biliary tract cancer
    • Cohort 2: Bladder cancer
    • Cohort 3: Cervical cancer
    • Cohort 4: Endometrial cancer
    • Cohort 5: Epithelial ovarian cancer
    • Cohort 6: Pancreatic cancer
    • Cohort 7: Rare tumors: This cohort will consist of patients with tumors that express HER2, excluding the tumors mentioned above, and breast, non-small cell lung cancer, gastric cancer, and colorectal cancer.
  • Progressed following prior treatment or who have no satisfactory alternative treatment option.
  • Prior HER2 targeting therapy is permitted.
  • HER2 expression for eligibility may be based on local or central assessment.
  • Has measurable target disease assessed by the Investigator based on RECIST version 1.1.
  • Has protocol- defined adequate organ function including cardiac, renal and hepatic function.
CRITÈRES D'EXCLUSION (EN)
  • Uncontrolled intercurrent illness
  • History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant severe illnesses
  • Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
  • Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART
  • Known Somatic DNA mutation of HER2 (ERBB2) without tumoral HER2 protein expression.
  • Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, adenocarcinoma of the gastric body or gastro-esophageal junction, or non-small cell lung cancer.