Pancreatic Cancer MSK 19-239

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.

Eligibility Criteria:

• Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.
• Subjects must have metastatic pancreatic cancer that has not been previously treated with chemotherapy.

• • Prior treatment with 5-FU or GEM administered as a radiation sensitizer during and up to 4 weeks after radiation therapy is allowed (if there is lingering toxicity, then the sponsor should be consulted).
  • If a subject received therapy in the adjuvant setting, tumor recurrence or disease progression must have occurred at least 6 months after completing the last dose of adjuvant therapy.
• Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measureable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
• Subject’s tumor sample has CLDN18.2 expression in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.

This study is for patients age 18 and older.

Available at: Hartford Hospital, Hospital of Central Connecticut and MidState Medical Center.