A Phase I Study of BI 905711 in People with Advanced Digestive Cancers

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Full Title

A First-in-Human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients with Advanced Gastrointestinal Cancers

Purpose

The purpose of this study is to find the highest dose of the investigational drug BI 905711 that can be given safely in patients with advanced digestive cancers that cannot be successfully treated with standard therapies. BI 905711 is a bispecific antibody: it binds to two different proteins (called TRAILR2 and CDH17) that are often found in gastrointestinal cancer cells.

TRAILR2 helps control the genes involved in cell growth and survival. BI 905711 locates the CDH17 protein on the surface of cancer cells and attaches to it. Once attached, it causes TRAILR2 proteins to group together, and this grouping eventually kills cancer cells. Healthy cells are not killed since they rarely have high levels of both proteins. BI 905711 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 advanced inoperable or metastatic colorectal, stomach, esophageal, pancreatic, gallbladder, or bile duct cancer that persists or came back despite conventional treatments.
  • Patients should recover from the serious side effects of prior treatments before receiving BI 905711.
  • 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 and to inquire about eligibility for this study, please contact Dr. James Harding at 646-888-4314.

Protocol

20-051

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators