Titre Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
Protocole ID SPARTA
ClinicalTrials.gov ID NCT03175224
Type(s) de cancer Poumon non à petites cellules
Phase Phase I-II
Stade Maladie avancée ou métastatique
Type étude Traitement
Médicament APL-101
Institution CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
   HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
      3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
Ville Montréal
Investigateur(trice) principal(e) Dr Jason Agulnik
Coordonnateur(trice) Daria Krutauz
 514-340-8222 poste 24301
Statut Actif en recrutement
Critètes d'éligibilité Major Inclusion Criteria:
  • Able to understand and comply with study procedures, understand the risks involved, and provide written informed consent.
  • For Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy.
  • For Phase 2, five cohorts will be enrolled: Cohort A-1: NSCLC EXON 14 skip mutation (c-Met naïve) for first line treatment, Cohort A-2: NSCLC EXON 14 skip mutation (c-Met naïve) pretreated subjects with no more than 3 lines of prior therapy, Cohort B: NSCLC EXON 14 skip mutation (c-Met experienced; radiographic progression on prior c-Met inhibitor), Cohort C: basket of tumor types with c-Met high level amplification (NSCLC EXON 14 skip mutation excluded), Cohort D: basket of tumor type with c-Met fusions.
  • Local/archival result (tissue and/or plasma) of a positive c-Met dysregulation is required
  • Measurable disease according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • No chemotherapy treatments within at least 3 weeks prior to first dose of study treatment
  • No planned major surgery within 4 weeks of first dose of APL-101
Critètes d'exclusion Major Exclusion Criteria:
  • Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
  • Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
  • History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
  • Unable to swallow orally administered medication whole.
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
  • Women who are breastfeeding.