A Phase I Study of NUV-422 in Patients with Recurrent or Persistent High-Grade Gliomas

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Full Title

A Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults with Recurrent or Refractory High-grade Gliomas

Purpose

The purpose of this study is to find the highest dose of the investigational drug NUV-422 that can be given safely in patients with high-grade glioma that has come back or continued to grow despite prior treatment. NUV-422 blocks proteins called CDKs that help glioma cells grow and survive. Blocking CDKs may slow or stop the growth of cancer. NUV-422 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 high-grade (stage III or IV) glioma that has come back or continued to grow despite up to two regimens of prior treatment.
  • At least 2 weeks must pass between the completion of previous treatment and receipt of NUV-422.
  • Patients must be able to 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 and to inquire about eligibility for this study, please contact Dr. Thomas Kaley at 212-639-5122 or the Brain Tumor Hotline at 866-886-9807.

Protocol

20-573

Phase

I/II

Investigator

Co-Investigators