5 results
The study described in this protocol is designed to determine the pharmacokinetics of cefotaxime and its metabolite, desacetyl-cefotaxime, in children on continuous intravenous infusion of cefotaxime. Using these data we will be able to delineate…
To assesses the efficacy of Tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1.
PRIMARY: Dose finding part (Phase 1):To assess the safety and tolerability of durvalumab when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab to determine the recommended Phase 2 doses (RP2Ds) of each…
Part A - Dose Finding/SafetyPrimary Objective:* To determine the recommended pediatric equivalent dose (RPED; based on pharmacokinetic [PK] and, if applicable,pharmacodynamic data) for use in pediatric subjects (age >=1 to <12 years)…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…