6 results
The primary objective of the study is to demonstrate the antitumor activity of LDK378.
Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…
The primary objective is to evaluate the antitumor activity of ceritinib in patients with ALK-positive NSCLC metastatic to the brain and/or toleptomeninges based on whole body overall response rate (ORR), defined as the proportion of patients with a…
Primary: 1. To determine the MTD and/or RDE of the combination ceritinib and nivolumab. 2. To assess the preliminary antitumor activity of the combination.Secondary: 1: To assess the safety profile of the ceritinib and nivolumab combination. 2: To…
Primary objectives: To evaluate safety of ZED88082A in combination with CED88004S. To determine appropriate ZED88082A/CED88004S dosing and PET imaging time-points. To evaluate pharmacokinetics (PK) of ZED88082A/CED88004S in patients before and…
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…