Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Recurrence

Carcinoma

Breast Neoplasms

Glioma

Prostatic Neoplasms

Glioblastoma

Prostatic Neoplasms, Castration-Resistant

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Disease Attributes

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

NUV-422 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached.

NUV-422 is an investigational drug for oral dosing.

NUV-422

At the time of study termination, NUV-422-02 was a first-in-human, open-label, Phase 1 dose escalation study designed to evaluate the safety and efficacy of NUV-422. The study population comprised 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 self-administered NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors

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

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)

Nuvation Bio Inc.

NUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

NUV-422 will be administered orally at the RP2cD in combination with enzalutamide.

160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

Enzalutamide

NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC

Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors	NCT04541225	Glioma Glioma, Maligna... Glioma, Mixed Glial Cell Tumo... Breast Cancer Breast Carcinom... Cancer of Breas... Cancer of the B... Breast Tumor Malignant Tumor... Advanced Breast... Advanced Breast... Metastatic Brea... Metastatic Brea... Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration-resi... Castration Resi... Glioblastoma Recurrent Gliob...	NUV-422	18 Years -	Nuvation Bio Inc.
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC	NCT05191017	Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration Resi... Castration Resi...	NUV-422 Enzalutamide	18 Years -	Nuvation Bio Inc.
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC	NCT05191017	Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration Resi... Castration Resi...	NUV-422 Enzalutamide	18 Years -	Nuvation Bio Inc.
Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors	NCT04541225	Glioma Glioma, Maligna... Glioma, Mixed Glial Cell Tumo... Breast Cancer Breast Carcinom... Cancer of Breas... Cancer of the B... Breast Tumor Malignant Tumor... Advanced Breast... Advanced Breast... Metastatic Brea... Metastatic Brea... Prostate Cancer Prostatic Cance... Cancer of Prost... Cancer of the P... Prostate Neopla... Castrate Resist... Castration-resi... Castration Resi... Glioblastoma Recurrent Gliob...	NUV-422	18 Years -	Nuvation Bio Inc.

Spots Global Cancer Trial Database for castration resistant prostatic neoplasms