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