A Phase I Study of BI 905677 in Patients with Advanced Solid Tumors

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Full Title

An Open-label, Phase I Trial to Determine the Maximum-Tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients with Advanced Solid Tumours

Purpose

The purpose of this study is to find the highest dose of the investigational drug BI 905677 that can be given safely in patients with persistent or inoperable solid tumors. BI 905677 targets a pair of proteins (LRP5/LRP6) that help control genes involved in cell growth and maturity, particularly in colorectal cancers.

Genes stimulated by LRP5/LRP6 may promote the growth of cancer cells and make cancer cells resistant to treatment. Blocking these proteins may therefore inhibit cancer growth or make cancers more vulnerable to cancer treatment. BI 905677 is given intravenously (by vein).

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 persists despite treatment or cannot be surgically removed.
  • At last 4 weeks must pass between the completion of prior treatment 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 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Rona Yaeger at 646-888-5109.

Protocol

18-525

Phase

I

Investigator

Co-Investigators