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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma, Cancer of the Breast, Cancer of Breast, Malignant Tumor of Breast, Breast Tumor

In brief

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.

Key facts

Study ID

NCT05191004

Run by

Nuvation Bio Inc.

People needed

0

Starts

2022-09-01

Expected to finish

2026-09-01

Last updated by the study team

2023-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women with diagnosis of locally advanced inoperable or metastatic HR+HER2- breast cancer
• Evidence of disease progression on immediate prior therapy as determined by the Investigator per standard criteria
• Patients must have received standard of care treatments for their breast cancer and be eligible to receive fulvestrant
• Prior standard of care treatments must include treatment with hormonal therapy in combination with an approved CDK4/6 inhibitor
• Patients must have endocrine-resistant disease
• Have no known active or symptomatic central nervous system (CNS) disease
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
• Life expectancy of > 6 months
• Eligible to receive fulvestrant
• Adequate bone marrow and organ function

You may not qualify if…

• Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs in male patients and premenopausal women), radiation, or biological anti-cancer therapy within 14 days prior to the first dose of NUV-422 and fulvestrant
• Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (of < 5 half-lives) for myelosuppressive agent prior to first dose of NUV-422 and fulvestrant
• Moderate liver impairment which would require a reduced dose of fulvestrant
• Requires medications that are known to be strong inducers and/or inhibitors of CYP3A4/5 enzymes
• For Phase 1b only: requires medications that are known to be moderate inducers and/or inhibitors of CYP3A4/5 enzymes
• Known allergy or hypersensitivity to fulvestrant
• For Phase 2 only: prior therapy with fulvestrant and/or investigational ER targeted agent
• Females who are pregnant or breast feeding

Where it is running

• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• Compassionate Cancer Care Research Inc. — Fountain Valley, California, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Pennsylvania Cancer Specialists and Research Institute — Gettysburg, Pennsylvania, United States
• NEXT Virginia — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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