A Phase I/II Study of [225Ac]-FPI-1966, [111In]-FPI-1967, and Vofatamab in People with Advanced Solid Tumors

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Full Title

A Phase 1/2 Study of [225Ac]-FPI-1966, [111In]-FPI-1967, and Vofatamab in Participants with FGFR3-expressing Advanced, Inoperable, Metastatic and/or Recurrent Solid Tumours

Purpose

The purpose of this study is to see if the radiotherapy drug [225Ac]-FPI-1966, the radiotracer [111In]-FPI-1967, and vofatamab are safe drugs that cause few or mild side effects in people with advanced, metastatic, inoperable, and/or recurrent solid tumors. [225Ac]-FPI-1966 is designed to target cancer cells that make a protein called FGFR3. [225Ac]-FPI-1966 gives off small doses of radiation that may be able to destroy these cancer cells.

[111In]-FPI-1967 is a radiotracer (a type of imaging agent) used to find cancer cells that make FGFR3. Participants will receive an injection of [111In]-FPI-1967 followed by imaging scans that will show whether their cancer cells make the FGFR3 protein.

Vofatamab is an antibody that attaches to FGFR3 on cancer cells. Researchers want to find out if the amount of radiation delivered to participants’ tumors changes when the radiotherapy drug [225Ac]-FPI-1966 is given alone or with vofatamab. The medications in this study are given intravenously (by vein).

Eligibility

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

  • Participants must have an advanced solid tumor that is inoperable, came back after prior treatment, or has spread (metastasized) to other parts of the body.
  • Patients must have cancers that cannot be treated successfully with standard therapies or for which no standard treatments exist.
  • 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.

Contact

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

22-200

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Diseases