6 results
The primary objective of the exploratory study is to characterize the types and dynamics of changes in the tumor microenvironment that occur following programmed-death-1 (PD-1) receptor blockade with REGN2810 and to assess their relationship to the…
Primary: i) To determine the optimal 89Zr-DFO-REGN3767 protein dose and optimal PET imaging timepoint. ii) To evaluate the pharmacokinetics (PK) of 89Zr-DFO-REGN3767 by measuring standardized uptake value (SUV) on 89Zr-DFO-REGN3767 PET scans in…
Primary ObjectivesAssess whether the finger tapping task endpoints:• Differentiate between ON and OFF states in PD patients• Correlate with the MDS-UPDRS part III total score• Differentiate between placebo and levodopa/carbidopa treatmentSecondary…
The purpose of the study is to investigate how quickly and to what extent balovaptan is absorbed and eliminated from the body when it is administered to healthy volunteers. The pharmacokinetics of balovaptan given by mouth (oral) will be compared…
Primary ObjectivesIn the Dose Escalation Phase:• To assess the safety and pharmacokinetics (PK) in order to determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimabIn…
Primary Efficacy Objective:Primary objective: To evaluate if the addition of ISA101b to cemiplimab results in improved overall response rate (ORR) compared to cemiplimab alone, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1…