Groupe d'Etude en Oncologie du Quebec

Titre	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
ClinicalTrials.gov ID	NCT06360354
Type(s) de cancer	Pancréas Voies biliaires
Phase	Phase I
Type étude	Clinique
Médicament	AMG 193 + gemcitabine et nab-paclitaxel versus AMG 193 + FOLFIRINOX modifié
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 Maxime Chénard-Poirier
Coordonnateur(trice)	Maryse Gingras 418-525-4444 poste 15781
Statut	Actif en recrutement
Critètes d'éligibilité	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.
Critètes d'exclusion	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.

Groupe d'étude en oncologie du Québec