A Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults with Recurrent or Refractory High-grade Gliomas and Solid Tumors
Trial Description: NUV-422-02 is a first-in-human, open-label, Phase 1/2 dose escalation and multiple expansion cohort study designed to evaluate the safety and efficacy of NUV-422. The study population is comprised of adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and without brain metastases, and recurrent or refractory metastatic castration-resistant prostate cancer (mCRPC). All patients will self-administer NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.
- Conditions: advanced breast cancer, advanced breast carcinoma, breast cancer, breast carcinoma, breast tumor, cancer of breast, cancer of prostate, cancer of the breast, cancer of the prostate, castrate resistant prostate cancer, castration resistant prostatic neoplasms, castration-resistant prostate cancer, glial cell tumors, glioblastoma, glioma, glioma malignant, glioma mixed, malignant tumor of breast, metastatic breast cancer, metastatic breast carcinoma, prostate cancer, prostate neoplasm, prostatic cancer, recurrent glioblastoma
- Phase: I/II
- Trial ID: NCT04541225
- Protocol ID: 20-517