13 results
Primary objective: - To determine the feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to identify dysplasia and/or malignant lesions in patients with Barrett*s esophagus. - To evaluate the safety of EMI-…
To demonstrate the superiority of the combination Nebivolol plus HCTZ versus Irbesartan plus HCTZ in terms of SBP reduction after 12 weeks of treatment in elderly patients with isolated systolic hypertension.
The primary objective of this study is to determine the safety and feasibility of fluorescence molecular endoscopy using the fluorescent tracer bevacizumab-800CW for identification of pathological complete response after neoadjuvant…
Main objective Monotherapy Cohorts (R/R CLL):• Identify the RP2D and the MTD of epcoritamab• Evaluate the safety and tolerability of epcoritamabExpansion Monotherapy (R/R CLL [Arm 1] and RS [Arm 2A]):• Assess the preliminary efficacy of…
Compare the clinical efficacy of Epcoritamab to SOC (R-GemOx or BR)
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab (E + R-CHOP) can prolong progression-free survival (PFS) compared with 6 cycles of standard R-…
The primary objectives of the study are to characterize the safety and toxicity profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of…
Dose Escalation PhasePrimary - Evaluate the safety and tolerability of epcoritamab in combination with other agents Secondary- Characterize the PK properties of epcoritamab- To evaluate pharmacodynamic markers linked to efficacy and mechanism of…
The primary objective of this study is to determine the feasibility and safety of quantitative fluorescence endoscopy using the fluorescent tracer durvalumab-680LT to get insight in the PD-L1 expression before and after neoadjuvant therapy in…
Primary:To evaluate the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in…
The primary objective of this pilot intervention study is to gain insight into vedolizumab distribution and to identify vedolizumab target cells in the inflamed gut, by performing in- and ex-vivo imaging using a tracer consisting of fluorescently…
This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.
Dose Escalation (GEN3009 for R/R B-cell NHL Including CLL/SLL):- Determine the MTD with and/or determine the RP2D of GEN3009- Evaluate safety and tolerability of GEN3009Expansion (GEN3009 for R/R, DLBCL, FL, and CLL Cohorts):-Evaluate (preliminary)…