TITRE Étude de phase 1b/3 associant Bermarituzumab/Chimiothérapie/Nivolumab versus Bermarituzumab/Chimiothérapie/Placebo chez les patients avec un adénocarcinome gastrique ou de la JGE non-traité, de stade avancé et surexprimant FGFR2b
PROTOCOLE ID FORTITUDE-102
CLINICAL TRIAL.gov ID NCT05111626
TYPE(S) DE CANCER Estomac
PHASE Phase I
TYPE D'ÉTUDE Clinique
INSTITUTION CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
VILLE Québec
INVESTIGATEUR(RICE) PRINCIPAL(E) Maxime Chénard-Poirier
COORDONATEUR(RICE) Maryse Gingras
maryse.gringras@chudequebec.ca
418-691-5781
STATUT  Fermé
CRITÈRES D'ÉLIGIBILITÉ (EN)

Inclusion Criteria Part 1 and Part 2:

  • Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
  • Participant has no contraindications to mFOLFOX6 chemotherapy or nivolumab
  • Adequate organ function as follows:

    • Absolute neutrophil count ≥ 1.5 x 10^9/L
    • Platelet count ≥ 100 x 10^9/L
    • Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
    • Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement)
    • Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's disease)
    • Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault
    • International Normalized Ratio (INR) or prothrombin time (PT) < 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment

Additional Inclusion Criteria Part 2:

  • No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
  • Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy.
CRITÈRES D'EXCLUSION (EN)
  • Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
  • Known positive human epidermal growth factor receptor 2 (HER2) status
  • Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
  • Peripheral sensory neuropathy grade 2 or higher
  • Clinically significant cardiac disease
  • Other malignancy within the last 2 years (exceptions for definitively treated disease)
  • Chronic or systemic ophthalmologic disorders
  • Major surgery or other investigational study within 28 days prior to randomization
  • Palliative radiotherapy within 14 days prior to randomization
  • Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
  • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study