17 results
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy.Timepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To evaluate the activity of FL-101…
The objectives of this extension trial are to assess the long-term safety and maintenance of efficacy beyond 2 to 2.5 years of treatment with glepaglutide in adult patients with SBS.Primary Objective:To evaluate the long-term safety of glepaglutide…
Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…
Primary objectives:The objective is to study the distribution of CD8+ T-cells before and after CAR T-cell therapy in the patient by ZED88082A/CED88004S-PET imaging. We will correlate the pretreatment CD8+ T-cell distribution and CD8+ CAR T-cell…
Primary Objective:To evaluate the efficacy of adagrasib monotherapy and in combination with pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation.Secondary Objectives:• To characterize the…
The primary objective is:• To evaluate the safety and tolerability of a single local i.c. dose of SI-053 to establish the MTD and/or the RP2D (dose escalation) and to further evaluate safety at the RP2D (dose expansion).The secondary objective is:•…
The current study is a confirmatory, randomized, double-blind, placebo-controlled, Phase III clinical trial to assess the efficacy and safety of PRM-151 in patients with IPF with or without concurrent treatment with pirfenidone or nintedanib.
Study WA42294 is a Phase III open-label extension (OLE) study to assess the long-term safety, efficacy, and pharmacokinetics of PRM-151 in patients with IPF with or without concurrent treatment with pirfenidone or nintedanib. Patients with IPF who…
Primary Objective:To assess the safety and tolerability and determine the MTD and the RP2D of CB307 in patients with PSMA+ tumoursSecondary Objectives:• To characterise the serum PK of CB307• To characterise the immunogenic potential of CB307 and…
Primary Objective:To evaluate the efficacy of LN-145 measured by objective response rate (ORR) usingResponse Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by theIndependent Review Committee (IRC) for Cohorts 1 and 2 and by the…
The objective of this study is to evaluate the efficacy and safety of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) at 24 weeks in adults with PAH.
Primary (Efficacy):To evaluate the efficacy of magrolimab + azacitidine compared with that of azacitidine + placebo in previously untreated participants with intermediate/high/very high risk MDS by IPSS-R as measured by CR rateTo evaluate the…
Core Primary Objectives:1. To investigate the safety and tolerability of EP0042 given alone or in combination with anti-cancer treatments.Module 1 Primary Objectives:1. To investigate the safety and tolerability of EP0042 given as a monotherapy in…
There is need for evidence-based and reproducible data comparing the safety, longevity and patient satisfaction propensity of the various HA soft tissue filler products. In a survey among 67 Dutch cosmetic physicians in 2014, the Dutch National…
The objective of this study is to evaluate the effects of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are…
Primary objectivesPart 1 Dose Escalation (with or without LDSC-IL2)• To investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC.• To determine the RP2D of LAVA-1207 in patients with therapy refractory mCRPC.…
The primary objective of this study is to assess the efficacy of twice-weekly SC doses of pegcetacoplan compared with that of placebo in patients with primary C3G or IC-MPGN on the basis of a reduction in proteinuria in the setting of stable or…