5 results
Objectives:Primary:• To determine the absolute bioavailability of niraparib by using an intravenous (IV) niraparibmicrodose of 100 µg (containing approximately 1 µCi of [14C]-niraparib) in subjects with cancer.Secondary:• To characterize 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 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…
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 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…