Louisville, Kentucky Clinical Trials

Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.

By enrolling patients with advanced NSCLC and metastatic TNBC according to the enrollment criteria, this study will evaluate the first-in-patient safety, PK, PD and early signs of efficacy of the vaccine-based immunotherapy regimen.

Based on pre-dose weight on Day -1, subjects weighing within the 3rd to < 97th percentile based on age - will receive a single, weight adjusted dose of ZTI-01 via continuous IV infusion or syringe pump over a 1- hour (+10 min) period. Pediatric subjects participating in this study will ...

To evaluate the safety and tolerability of AMG 404, a monoclonal antibody that binds to PD-1 and inhibits its engagement with ligands, in patients with advanced solid tumors.

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of two parts: Part 1 is multiple-cohort study that consists of two sequential multiple-ascending dose groups. Participants benefiting from the study drug with no ongoing adverse ...

In the study, a maximum of 48 subjects (18 for the combination with abiraterone/prednisone and 30 for the combination with enzalutamide) will be enrolled initially at a dose of 400 mg tazemetostat twice daily, followed by 600 mg tazemetostat twice daily, followed by 800 mg tazemetostat twice daily, if there ...

The study will be conducted on multiple centers (10) in USA and Spain. The study design allows an exploration of different doses with intensive safety monitoring to ensure the safety of the patients. The two planned combination treatments during Part A of this study are: Part A1: Capivasertib and enzalutamide ...

This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.

The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with recurrent CSCC. The secondary objectives of this study are: To describe the objective response rate (ORR) in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC, according to modified ...

A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in subjects with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.