19 results
The primary objective of the study is to determine the MTD (Maximally Tolerated Dose) of SGN-40 from among three possible dose levels when combined with a standard dose of bortezomib and to determine the safety and adverse event profile for…
The primary objectives of the study are:- to establish the optimal dose of the combination for second-line therapy with NAMI-A and Gemcitabine (Phase I part)- to assess the response rate according to RECIST criteria (Phase II part) in advanced NSCLC…
1. Increase detection and localization of epileptogenic lesions using non-invasive TMS stimulation of suspect region's2. Decrease invasiveness and/or improve the accuracy of the presurgical evaluation by comprehensive noninvasive testing of…
Primary objectivePart 1: To investigate whether sTHC is released from a new chewing gum formulation.Part 2: To investigate the bioavailability of THC from chewing gum using dronabinol capsules as comparator in healthy male and female subjects.…
Primary:Part A: To assess the safety and tolerability of single ascending doses of DMT in healthy subjects, when given by IV infusion. Part B: To assess the safety and tolerability of fixed repeated doses of DMT in healthy subjects, when given three…
Primary objective - To assess the efficacy of q4w x3 i.a. injections of LRX712 in restoring the morphometrics of articular cartilage in the medial femoral condyleSecondary objectives- To evaluate LRX712 and metabolite MAE344 pharmacokinetics in…
Dose Expansion:Primary Objective-*To investigate the antitumor activity of HE3-DXdSecondary Objectives-*To assess the safety and tolerability of HE3-DXd in metastatic or unresectable NSCLC subjects-*To characterize the PK of HE3-DXd, total anti-HER3…
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…
Primary:•To compare the effect of venglustat with standard of care Fabry therapies on left ventricular mass index over 18 months in participants with Fabry disease and left ventricular hypertrophySecondary:•To evaluate the effect of venglustat on…
The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of BMS-986016 administered alone and in combination with nivolumab in subjects with advanced solid tumors.The co-…
To evaluate the effect of AZD4831 as compared to placebo on the time to first COPDCompEx event in participants with moderate to severe COPD.
Primary objectivePhase I: To determine the recommended phase II dose (RP2D) of the combination treatment with nivolumab and entinostat administered to adolescents 12-21 years with progressive, relapsed , refractory high-risk solid tumors and CNS…
Objectives Part A: • To evaluate the safety and tolerability of CIT-013 after administration of single, ascending, IV doses in healthy volunteers.• To evaluate the pharmacokinetics of CIT-013 after administration of single, ascending, IV doses in…
Primary objective: To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD.Secondary objectives:• To evaluate the safety and tolerability of inebilizumab in patients with IgG4-RD.• To evaluate the…
Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2 sequential periods - an initial double-blind placebo-controlled period of minimum 72 weeks followed by a double-blind…
1. Assessing the efficacy of IVIg in autoimmune epilepsy, both clinically and serologically.2. Identifying an objective marker of therapy response in epilepsy, measuring cortical excitability by TMS-EEG/EMG, in vivo.3. Providing evidence that…
Primary• To investigate the safety and tolerability of multiple oral doses of DNL343 in participants with ALSSecondary• To characterize the PK of DNL343 in plasma following single and multiple oral doses• To characterize the concentration of DNL343…
To compare the 120 mg once daily (QD) dose and 200 mg QD dose of MK*6482with respect to objective response rate (ORR) based on Response Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
The objectives of this follow-up study of the EPITOPE study are:• To assess the clinical benefit of Viaskin Peanut after up to 3 years of epicutaneous immunotherapy (EPIT) to induce/maintain desensitization to peanut in peanut-allergic children;• To…