Title 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
Cancer Type(s) Solid Tumors
Phase Phase I
Stage
Study Type Clinical
Drug PF-07799544
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   SITE GLEN
      1001 boul. Décarie , Montréal, QC, H4A 3J1
City
Principal Investigator Dr. Ramy Saleh
Coordinator Abdul-Rahman El-Hassan
514-934-1934 poste 35161
Status Recruiting
Activation Date 14-02-2024
Eligibility Criteria
  • 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
Exclusion Criteria
  • 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)