SOUSEIKAI Global Clinical Research Center

Safety, tolerability and pharmacokinetics of an NMDA receptor subunit 2B-selective negative allosteric modulator, BI 1569912: Results of three partially randomised, placebo-controlled phase I trials

Background: BI 1569912 is an orally administered, GluN2B-selective negative allosteric modulator at the N-methyl-D-aspartate receptor. Aims: To investigate the safety, tolerability and pharmacokinetics (PK) of BI 1569912 in healthy males across three partially randomised, placebo...

Long-Term Survival Outcomes of Modified-FOLFOXIRI Plus Cetuximab Versus Bevacizumab in RAS / BRAF Wild-Type Metastatic Colorectal Cancer: Final Analysis of the DEEPER Trial

The randomized phase II DEEPER trial (jRCTs061180022) previously reported superior depth of response with modified 5-fluorouracil, leucovorin, oxaliplatin and irinotecan (m-FOLFOXIRI) plus cetuximab versus bevacizumab in patients with RAS wild-type metastatic colorectal cancer (m...

A Case of Cytokine Release Syndrome (CRS) Related to Treatment With Lenvatinib Plus Pembrolizumab for Metastatic Clear Cell Renal Cell Carcinoma

ABSTRACT Introduction Cytokine release syndrome (CRS) is a systemic inflammatory response triggered by various factors, including infection and immunotherapy. Due to its nonspecific presentation, distinguishing CRS from other life‐threatening conditions remains challenging. Case...