Clinical Evaluation of ICOS Stimulation Using Feladilimab
tumor
TUMOR, SOLID TUMORS
On the basis of the nonclinical evidence supporting the utility of anti–ICOS-based costimulation to promote antitumor responses, we initiated an ongoing first-in-human clinical trial (INDUCE-1; NCT02723955) to translate these findings to patients with advanced solid tumors in the clinic. The study was designed to evaluate the safety/tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of feladilimab alone and in combination with other anticancer agents, including pembrolizumab. A range of feladilimab doses as a monotherapy and in combination with pembrolizumab (200 mg once every 3 weeks) were being investigated in the dose-escalation phase of the trial, and the dose-expansion phase is further evaluating feladilimab at doses selected in the dose-escalation phase.Pharmacodynamic and tumor response analyses using immune-related and RECIST v1.1 assessments from patient case studies from INDUCE-1 provided proof-of-concept support for the clinical evaluation of an ICOS agonist as monotherapy and in combination with PD-1 blockade (Clinical patient case studies of feladilimab monotherapy and in combination with pembrolizumab. 