Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Fulvestrant

Estrogens

Mitogens

Antineoplastic Agents, Hormonal

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

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

500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

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

500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

NUV-422 will be administered orally at the RP2cD.

500 mg fulvestrant will be administered IM on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter.

NUV-422 is an investigational drug for oral dosing.

NUV-422

NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy. The study population is comprised of adults with HR+HER2- aBC. Patients will self-administer NUV-422 orally in 28-day cycles and receive 500 mg fulvestrant intramuscularly (IM) on Days 1 and 15 of Cycle 1 and Day 1 of every cycle thereafter. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Sequential assignment or parallel assignment will be applied (in both Phase 1 and Phase 2), depending on the stage of the study at the time of a patient's enrollment.

Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC

Randomized, Non-Comparative Phase 1/2 Study of NUV-422 in Combination With Fulvestrant in Patients With Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative (HR+HER2-) Advanced Breast Cancer (aBC)

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

Nuvation Bio Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC	NCT05191004	Advanced Breast... Metastatic Brea... Breast Cancer Breast Carcinom... Cancer of the B... Cancer of Breas... Malignant Tumor... Breast Tumor	NUV-422 Fulvestrant	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 Combination With Fulvestrant in Patients With HR+HER2- aBC	NCT05191004	Advanced Breast... Metastatic Brea... Breast Cancer Breast Carcinom... Cancer of the B... Cancer of Breas... Malignant Tumor... Breast Tumor	NUV-422 Fulvestrant	18 Years -	Nuvation Bio Inc.

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