Titre A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors
Protocole ID DESTINY-PanTumor02
ClinicalTrials.gov ID NCT04482309
Type(s) de cancer Tumeurs solides
Phase Phase II
Type étude Clinique
Médicament Trastuzumab Deruxtecan
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL DE L'ENFANT-JESUS
      1401 18e Rue, Québec, QC, G1J 1Z4
Ville Québec
Investigateur(trice) principal(e) Dr Olivier Dumas
Coordonnateur(trice) Marie-Pierre Brochu
 418-525-4444 poste 15768
Statut Actif en recrutement
Date d'activation 03-06-2024
Critètes d'éligibilité
  • 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.
Critètes d'exclusion
  • 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.