A Phase I Study of 177Lu-DOTA-EB-TATE in People with Advanced Neuroendocrine Cancers

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Full Title

Phase I, Open-Label Study of the Safety and Dosimetry of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients with Advanced, Well-Differentiated Neuroendocrine Tumors

Purpose

The purpose of this study is to find the highest dose of 177Lu-DOTA-EB-TATE that can be given safely in people with previously untreated advanced neuroendocrine digestive cancers that absorb high amounts of the hormone somatostatin and its synthetic analogues (chemical cousins). The main function of somatostatin is to prevent the production of other hormones. People with neuroendocrine tumors often make too many copies of a protein called the somatostatin receptor

177Lu-DOTA-EB-TATE may help people with advanced neuroendocrine cancers because it binds well to the somatostatin receptor on cancer cells and releases radiation to destroy those cancer cells. It is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must be newly diagnosed with a neuroendocrine tumor of the digestive tract (including the pancreas, stomach, colon, rectum, or appendix) that has spread beyond its original location.
  • Patients’ tumors must present high amounts of somatostatin receptors, as detected using a special somatostatin receptor PET scan.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Lisa Bodei at 212-639-7373.

Protocol

21-362

Phase

I

Investigator

Co-Investigators

Joseph O'Donoghue

ClinicalTrials.gov ID

NCT05475210