A Phase 1 Study of Zolbetuximab Plus Chemotherapy in People With Advanced Pancreatic Cancer

Share

Full Title

A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination with Chemotherapy (mFOLFIRINOX) in Participants with CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

Purpose

Researchers want to see if giving zolbetuximab with chemotherapy is safe in people with pancreatic cancer. The people in this study have pancreatic cancer that has metastasized (spread). In addition, their tumors make a protein called CLDN18.2, which plays a role in cancer growth.

The chemotherapy in this study is mFOLFIRINOX, which includes oxaliplatin, leucovorin, irinotecan, and fluorouracil. If you join this study, you will get mFOLFIRINOX with zolbetuximab, which blocks CLDN18.2. These medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic pancreatic cancer that makes CLDN18.2.
  • Have not received chemotherapy for advanced disease.
  • Not have experienced pancreatic cancer growth after previously receiving mFOLFIRINOX.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Wungki Park’s office at 646-888-4543.

Protocol

24-382

Phase

Phase I (phase 1)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06396091