A Phase I Study of LOXO-195 for Adults and Children with Advanced Cancers Containing NTRK Mutations

Full Title

A Phase 1/2 Study of the TRK Inhibitor LOXO 195 in Adult and Pediatric Subjects with Previously Treated NTRK Fusion Cancers

Purpose

TRK fusions occur when an NTRK gene (NTRK1, NTRK2, or NTRK3) becomes mistakenly connected to an unrelated gene. This can lead to relentless TRK signaling and uncontrolled cell growth that leads to cancer. Other NTRK mutations can also fuel cancer growth.

LOXO-195 is an investigational drug designed to treat cancers that have mutations in the NTRK genes, including gene fusions and other alterations. In this study, researchers want to find the highest dose of LOXO-195 that can be given safely in patients with advanced NTRK-mutated cancers that continue to grow despite prior treatment with a TRK inhibitor. LOXO-195 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 solid tumor that contains an NTRK fusion or other NTRK mutation and continues to grow despite prior treatment with a TRK inhibitor.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Hyman at 646-888-4226.

Protocol

17-323

Phase

I/II

Investigator

Co-Investigators