A Phase I Study of Codrituzumab in Children and Young Adults with Recurrent or Persistent Solid Tumors

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Full Title

A Multi-Center Phase I Study of Codrituzumab in Pediatric Patients with Relapsed or Refractory Glypican 3 (GPC3) Expressing Extra-Cranial Solid Tumors.

Purpose

The purpose of this study is to find the highest dose of the investigational drug codrituzumab that can be given safely in children and young adults with solid tumors that came back or continued to grow despite treatment. Codrituzumab works by targeting a protein called GPC3, which can drive the growth of some forms of cancer that affect children and young adults. It 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 a solid tumor that came back or continued to grow despite prior treatment.
  • Patients’ tumors must make the GPC3 protein, which is most often seen in these childhood cancers: hepatoblastoma, hepatocellular carcinoma, undifferentiated embryonal sarcoma of the liver, rhabdomyosarcoma, rhabdoid tumor, and Wilms tumor.
  • Patients should recover from the serious side effects of previous therapies before receiving codrituzumab.
  • This study is for patients age 1-21 years.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

20-489

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators