Phase II, Open-Label, Randomized Study to Assess the Antitumor Activity and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Summary
The purpose of this phase II study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment. This study will also evaluate other anti-tumor effects, tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM.
General Information
NCT#: NCT03816163
Study ID: 8951-CL-5201
Trial Phase: Phase II
Trial Sponsor: Astellas Pharma, Inc.
Therapies Used in This Trial: Nab-paclitaxel, Gemcitabine, Zolbetuximab