A Phase I Study of Oral CLR457 in Patients with Advanced Solid Tumors

Full Title

A Phase I/II Multicenter, Open-label Study of CLR457, Administered Orally in Adult Patients with Advanced Solid Malignancies


PI3 kinase is an enzyme that drives the growth of many types of cancer. CLR457 is an investigational drug designed to inhibit cancer growth by blocking the activity of PI3 kinase.

The purpose of this study is to find the highest dose of CLR457 that can be given safely in patients with advanced solid tumors that persist despite standard therapy or for which no standard therapy exists. CLR457 is given orally (by mouth).


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 persists despite standard therapy or for which no standard therapy exists.
  • Patients’ tumors must contain one or more of the following molecular features: PI3KCA mutation or amplification, loss of PTEN function, EGFR mutation, cMET activation, and/or HER2 overexpression.
  • At least 2-4 weeks must pass between the completion of prior therapies and entry into the study, and patients must recover from any serious side effects.
  • Patients may not have experienced tumor growth after receiving prior treatment with AKT, mTOR, or PI3 kinase inhibitors.
  • Patients must be able to be walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. James J. Harding at 646-888-4314.