Titre A phase 1A/B open-label master study of PF-07799544 as a single-agent and in combination with other targeted agents in participants with advanced solid tumors
Protocole ID C4901001
ClinicalTrials.gov ID NCT05538130
Type(s) de cancer Tumeurs solides
Phase Phase I
Type étude Clinique
Médicament PF-07799544
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 Olivier Dumas
Coordonnateur(trice) Geneviève Rochette
 418-525-4444 poste 67540
Statut Actif en recrutement
Date d'activation 10-07-2023
Critètes d'éligibilité
  • Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation
  • Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation
  • For Substudy A and B, histological or cytological diagnosis of advanced/metastatic melanoma
  • For Substudy A and B, measurable disease by RECIST version 1.1
  • For Substudy A, evidence of a BRAF V600 mutation in tumor tissue and/or blood
  • For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II alteration in tumor tissue and/or blood
Critètes d'exclusion
  • Brain metastasis larger than 4 cm
  • Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
  • For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)