A Phase II Study of Zolbetuximab plus Nab-paclitaxel and Gemcitabine to Treat Metastatic Pancreatic Cancer

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Full 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

Purpose

The purpose of this study is to assess the safety of the investigational drug zolbetuximab and to see if combining it with the drugs nab-paclitaxel and gemcitabine is safe and effective for treating metastatic pancreatic cancer. Zolbetuximab targets a protein called CLDN18.2, which is abundant on the surface of some pancreatic cancer cells. Zolbetuximab may help recruit immune cells to act against CLDN18.2, resulting in cancer cell death.

Researchers think that adding zolbetuximab to standard chemotherapy may make this treatment more effective in people whose metastatic pancreatic cancer makes the CLDN18.2 protein. All of the medications in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic pancreatic cancer that has not yet been treated with medication. Patients may have received prior chemotherapy for pancreatic cancer, but no chemotherapy after the cancer spread.
  • Patients must have evidence of the CLDN18.2 protein in at least 75 percent of their tumor cells.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Wungki Park at 646-888-4543.

Protocol

19-239

Phase

II

Investigator

Co-Investigators