Voies biliaires

TITRE (EN) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion
PROTOCOLE ID 20230223
CLINICAL TRIAL.gov ID NCT06360354
TYPE(S) DE CANCER Voies biliaires
PHASE Phase I
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC
1401 18e Rue
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Maxime Chénard-Poirier
COORDONATEUR(RICE) Maryse Gingras
maryse.gingras@chudequebec.ca
418-525-4444 poste 15781
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
  • Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.
  • Homozygous MTAP-deletion.
  • Disease measurable as defined by RECIST v1.1.
  • Adequate organ function as defined in the protocol.
CRITÈRES D'EXCLUSION (EN)
  • Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
  • Radiation therapy within 28 days of first dose.
  • Major surgery within 28 days of first dose of AMG 193.
  • Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
  • Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
  • History of solid organ transplantation.