Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) in Adult Subjects with Advanced Refractory Solid Tumor Malignancies
Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) in Adult Subjects with Advanced Refractory Solid Tumor Malignancies
1 PagesUS +1 (713) 559-7900 Europe +44 (0) 1344 891121 info@pharm-olam.com Programmed Cell Death Receptor-1 (PD-1) Inhibitor Monoclonal Antibody (mAb) in Adult Subjects with Advanced Refractory Solid Tumor Malignancies 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 78 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 verific
