A Phase I Study of BI 907828 in Patients with Recurrent or Persistent Advanced Solid Tumors

Full Title

A Phase Ia/Ib, Open Label, Multicenter, Dose-Escalation Study of BI907828 in Patients with Advanced or Metastatic Solid Tumors

Purpose

The purpose of this study is to determine the highest dose of the investigational drug BI 907828 that can be given safely in patients with advanced solid tumors that have continued to grow despite treatment. The drug will be assessed at different doses and dosing schedules.

BI 907828 works against cancer by blocking the activity of a protein called MDM2. Normal MDM2 helps cells to grow and then die, but when MDM2 is damaged, cancer cells can grow continuously. BI 907828 works when a patient’s tumor has normal, functioning p53 (a protein which puts the brakes on rampant cell growth), so patients in this study must have tumors with normal p53. BI 907828 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 has come back or continued to grow despite standard treatment, or for which no standard treatment exists.
  • Patients’ tumors must have normal p53.
  • At least 4 weeks must pass since the completion of prior therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Curtis Chong at 848-225-6149.

Protocol

18-256

Phase

I

Investigator

Co-Investigators