NCT05191004

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)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nuvation Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Breast Cancer
• Metastatic Breast Cancer
• Breast Cancer
• Breast Carcinoma
• Cancer of the Breast
• Cancer of Breast
• Malignant Tumor of Breast
• Breast Tumor

Interventions

Type	Name	Description
DRUG	NUV-422	NUV-422 is an investigational drug for oral dosing.
DRUG	Fulvestrant	Fulvestrant

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-06-01
• Completion: 2026-09-01
• First posted: 2022-01-13
• Last updated: 2023-07-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study