116 results
Three cohorts will be included consisting of subjects with biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and all other solid tumorhistologies not included in Cohorts 1-2 such as NSCLC, head and neck cancer, thyroid cancer, oral…
To establish preliminary safety and tolerability of single- and multiple-ascending oral doses of MYK 491 in ambulatory patients with stable heart failure with reduced ejection fraction (HFrEF)
The primary objectives of this study are:* To evaluate tracer kinetic models for the purpose of quantifying specific binding of 18F-AV-1451 in cross sectional and longitudinal applications; and* To evaluate simplified methods for quantification of…
To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide prolongs overall survival (OS) in subjects with newly diagnosed GBM harboring EGFR amplification.
The primary objective is to evaluate the efficacy of V565 555 mg TID in subjects with active CD measured by the proportion of subjects achieving response to therapy. Response is defined as reduction in the Crohn's Disease Activity Index (CDAI)…
Primary: Evaluate the efficacy of patient-derived tumor organoids to successfully allocate patients for treatment with specific targeted agents.Secondary: Characterize safety and tolerability per experimental treatment regimen.
Primary ObjectivePhase Ia* To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)and assess the safety of single agent GDC-0810 in postmenopausal women with locally advanced or metastatic estrogen-receptor-positive (ER…
The primary objectives of this study are:1. To evaluate the safety and tolerability of PTG-1002. To evaluate the efficacy of PTG-100 in the induction treatment of subjects with moderate to severe active UC compared to placebo.The secondary…
The primary objectives of the study are:For Parts A through C:1. Evaluate the safety and tolerability of multiple doses of CX-072, administered as monotherapy or in combination with ipilimumab or vemurafenib to patients with metastatic or locally…
The primary objective of this study is to assess the noninferiority of ALXN1210 compared to eculizumab in adult patients with PNH who have never been treated with a complement inhibitor. Noninferiority will be claimed if after 26 weeks of treatment…
Safety objective: To evaluate the safety and tolerability of UTTR1147AExploratory Efficacy Objective: To evaluate the efficacy of UTTR1147AExploratory Pharmacokinetic Objective: To evaluate potential relationships between long-term drug exposure and…
The objective of the study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.
Primary* To compare TFFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with LOXO-292 versus cabozantinib or vandetanib.Secondary* To compare other efficacy outcomes, based on RECIST 1.1 criteria, observed in…
The objective of this study is to evaluate the effect of cabozantinib compared with placebo on overall survival in subjects with advanced HCC previously treated with sorafenib.
Safety ObjectiveThe safety objective for this study is as follows:* To evaluate the safety and tolerability of atezolizumab in pediatric and young adult patients, focusing on the nature, frequency, and severity of serious and non-serious adverse…
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 prospective, multi-center trial is to assess the effectiveness of the Carillon Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR).
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…
The objectives of Part B of the study are as follows: Primary: To assess the safety and tolerability of CALY-002 following multiple ascending doses administered IV in subjects with coeliac disease (CeD). Secondary: (1) To characterise the PK of CALY…