A Phase I Study of TPX-0046 in People with Advanced or Metastatic Solid Tumors with Changes in the RET Gene

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Full Title

A Phase 1/2 Study of TPX-0046, A Novel Oral RET/SRC Inhibitor in Adult Subjects with Advanced/Metastatic Solid Tumors Harboring Oncogenic RET Fusions or Mutations

Purpose

The purpose of this study is to find the highest dose of the investigational drug TPX-0046 that can be given in patients who have advanced or metastatic cancers with a change in the RET gene, and to see what effects, if any, TPX-0046 has on these cancers. TPX-0046 targets the RET protein. When this protein is blocked, cancers that rely on RET may stop growing. TPX-0046 is taken orally (by mouth).

Eligibility

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

  • Patients must have an advanced or metastatic solid tumor with a RET mutation that cannot be cured using standard therapies or for which no standard therapy exists.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • 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. Alexander Drilon at 646-888-4206.

Protocol

20-045

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators