A Study to Assess the Efficacy and Safety of 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

• Status: Recruiting
• Trial end date: 2025-04-30

Summary

The purpose of this 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 tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).

• Phase: Phase 2

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Gemcitabine; Paclitaxel