A Phase I/II Study of [225Ac]-FPI-1434 in People with Advanced or Metastatic Solid Tumors

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Full Title

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients with Locally Advanced or Metastatic Solid Tumours

Purpose

The purpose of this study is to find the highest dose of the investigational radiotherapy drug [225Ac]-FPI-1434 that can be given safely in people with solid tumor cancers that have metastasized despite prior treatment. [225Ac]-FPI-1434 is designed to target cancer cells that make a protein called IGF-1R. [225Ac]-FPI-1434 gives off small doses of radiation that can destroy these cancer cells. Patients in this study will have a special test to see if their cancer cells make IGF-1R.

Some participants may also receive treatment with FPI-1175. The researchers want to learn if the amount of radiation delivered to a tumor changes when [225Ac]-FPI-1434 is given alone or with FPI-1175. The treatments used in this study are given intravenously (by vein).

Eligibility

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

  • Participants must have metastatic cancer that has continued to grow despite prior treatment. Their tumors will be tested at Memorial Sloan Kettering to see if the cells make IGF-1R.
  • At least 2 weeks must pass between the completion of previous chemotherapy or radiation therapy (6 months since receiving a radiation-emitting drug) and receipt of the study treatment.
  • 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. Neeta Pandit-Taskar at 212-639-3046.

Protocol

21-497

Phase

I/II

Investigator

Diseases