7 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 evaluate the ability to concentrate the radiotracer within the prostate gland improving the evaluation of the primary prostate tumor. Secondary Objective(s): * To evaluate the PET/CT imaging characteristics of transcatheter,…
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…
The primary study objective is to compare: - Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. The secondary objectives are to assess: - Impact on patient treatment/management. - Per-region detection rate of 18F-DCFPyL…
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…