13 results
The primary objective of the study is to quantitatively determine the PK (distribution, metabolism, and excretion) of 14C-vosaroxin and its metabolites in patients with advanced solid tumors.The secondary objective is to evaluate safety and…
The aim of this prospective, multicentre randomized phase II study is to evaluate the safety and efficacy of the combination of capmatinib and spartalizumab in subjects with EGFR weight (for exon 19 deletions and exon 21 L858R substitution mutations…
Primary: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus, HDM201, QBM076 or panobinostat and to identify recommended doses and schedules for future studies.Secondary: To characterize changes in the immune…
Primary:To evaluate the efficacy of pegcetacoplan in improving the underlying pathophysiology of complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN) after 12 weeks of treatment.Secondary:• To evaluate…
The purpose of this study is to allow collection of safety and tolerability data in subjects benefitting from treatment with spartalizumab as a single agent or in combination with other study treatments in a pre-defined (Appendix Section 16.1)…
Primary: To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future dosesSecondary:* To characterize the pharmacokinetic profile of each investigational drug within each treatment arm…
Primary objective:To characterize safety and tolerability of each treatment arm tested and identify recommended doses (RD) and regimens for future studies, by assessing the incidence and severity of AEs and SAEs; including changes in laboratory…
Objectives:Primary: To evaluate the long-term safety of IVT injected pegcetacoplanSecondary:1. To assess changes in the total area of geographic atrophy (GA) lesion in the study eye measured by fundus autofluorescence (FAF).2. To assess changes in…
The objectives of the study are to assess safety and tolerability, pharmacokinetics (PK), and biological activity (including efficacy and pharmacodynamics [PD]) of multiple subcutaneous doses of pegcetacoplan in pediatric patients with paroxysmal…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
Primary: • Part 1:To evaluate the efficacy of NIR178 and PDR001 combination in patients with selected advanced solid tumors and diffuse large B cell lymphoma (DLBCL). • Part 2: To assess the efficacy of several intermittent dosing schedules of…
Primary To evaluate the efficacy of Pegcetacoplan compared to sham injection in patients with GA secondary to AMD assessed by change in the total area of GA lesions from baseline as measured by FAF.Key SecondaryTo evaluate the efficacy of…
Primary: To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine or azacitidine in relapsed/refractory AML patients, de novo AML patients not candidates for standard induction therapy, or high risk or…