6 results
The primary objective of this study is to show bioequivalence between nitisinone oral suspension and nitisinone capsules.Secondary objectives of this study are:- To assess the effect of food on the bioavailability of nitisinone oral suspension.- To…
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 Objective• To assess the safety and tolerability of long-term tofacitinib therapy in subjects with UC.Secondary Objectives• To evaluate the efficacy of long term tofacitinib therapy in subjects with UC.• To evaluate the effect of long term…
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 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…