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Oncology Case Study: (PD-1) Inhibitor Monoclonal Antibody (mAb)

Case Study Description:Pharm-Olam was contracted to manage and recruit four sites for Phase I, first-in-human research of a PD-1 drug treatment for solid tumor malignancies. The study consisted of 18 patients. These participants were monitored for drug safety, PK, and efficacy. Six cohorts were tested on six different doses or treatment frequencies.


Pharm-Olam reached target enrollment 77 days ahead of schedule. The study needed to be escalated to reflect a high recruitment rate. The cohort management and monitoring strategy evolved to support the quick enrollment and the source data verification that stemmed from it.


Program Overview: Phase I, First-in-man
Indication: Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) in Adult Subjects with Advanced Refractory Solid Tumor Malignancies


Sites & Locations: 4 sites in the United States


Pharm-Olam Services:

  • Feasibility & Site Solutions
  • Project Management
  • Clinical Operations & Trial Management
  • Data Management
  • Medical Affairs & Pharmacovigilance
  • Patient Engagement Services
  • Biostatistics
  • Medical Writing
  • Quality Assurance