First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : I
Étape du traitement : Thérapie ciblée
Date d'ouverture : 02/09/2020
Date clôture : 31/10/2024
Promoteur : Relay Therapeutics, Inc.
Progression du cancer: Loco-régional et à distance
Résumé :

Il s'agit d'une étude FIH en ouvert conçue pour évaluer l'innocuité, la tolérabilité, la pharmacocinétique, la pharmacodynamie et l'activité antinéoplasique préliminaire de RLY-4008, un inhibiteur puissant et hautement sélectif du récepteur du facteur de croissance des fibroblastes 2 (FGFR2) administré par voie orale à des patients non résécables ou ICC métastatique et autres tumeurs solides non résécables ou métastatiques. Cette étude se compose de 2 parties, une escalade de dose (Partie 1) et une extension de dose (Partie 2).

Domaines/spécialités :
  • Autres
Biomarqueurs :
  • FGFR2
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :
  • Histologically or cytologically confirmed unresectable or metastatic solid tumor
  • Documented FGFR2 gene fusion, mutation, or amplification per local testing of blood and/or tumor
  • Additional FGFR2 alterations/tumor types may be considered for the Part 1 dose escalation

  • Part 2 dose expansion patients must additionally meet the group requirements detailed below.

    • Group 1: patient must have a confirmed diagnosis of unresectable or metastatic ICC with FGFR2 fusion (per local assessment of blood and/or tumor) and has received prior treatment with a pan-FGFR inhibitor (eg, pemigatinib, erdafitinib, infigratinib, futibatinib).
    • Group 2: patient must have a confirmed diagnosis of unresectable or metastatic ICC with FGFR2 fusion (per local assessment of blood and/or tumor) and has NOT received prior treatment with a pan-FGFR inhibitor (eg, pemigatinib, erdafitinib, infigratinib, futibatinib).
    • Group 3: patient has an unresectable or metastatic solid tumor with FGFR2 fusion (per local assessment of blood and/or tumor) other than ICC.
    • Group 4: patient has an unresectable or metastatic solid tumor with FGFR2 amplification (per local assessment of blood and/or tumor).
    • Group 5: patient has an unresectable or metastatic solid tumor with an oncogenic FGFR2 mutation (per local assessment of blood and/or tumor).
  • Patient must have disease that is refractory to standard therapy, disease that has not adequately responded to standard therapy, disease for which standard or curative therapy does not exist, or the patient must be intolerant to or have declined standard therapy
  • Patient must have measurable or evaluable disease per RECIST v1.1
  • Patient has ECOG performance status of 0-1
Critères d’exclusion :
  • Ongoing, clinically significant FGFR inhibitor-induced retinal detachment or an ongoing clinically significant corneal or retinal disorder
  • Patient does not have adequate organ function (defined in protocol)
  • Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol)
  • QT interval corrected using Fridericia's formula (QTcF) > 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome
  • Clinically significant, uncontrolled cardiovascular disease
  • CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Pr GHIRINGHELLI
Prénom : François
Téléphone : Non disponible
Email : fghiringhelli@cgfl.fr
CONTACT TECHNIQUE
Aucun contact technique renseigné

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