Trial Identifiers
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Scientific Title
A Phase 2, 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 Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Commercial Sponsor
Astellas Pharma Inc.
Summary
Eligible participants will be randomised to receive gemcitabine and nab-paclitaxel alone OR in combination with zolbetuximab at an escalating (Phase 1) or recommended (Phase 2) dose. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.