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

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05191004
• Other study ID #: NUV-422-03
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 2022
• Est. completion date: September 2026

Study information

• Verified date: July 2023
• Source: Nuvation Bio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women with diagnosis of locally advanced inoperable or metastatic HR+HER2- breast cancer

2. Evidence of disease progression on immediate prior therapy as determined by the Investigator per standard criteria

3. 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

4. Patients must have endocrine-resistant disease

5. Have no known active or symptomatic central nervous system (CNS) disease

6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) = 1

7. Life expectancy of > 6 months

8. Eligible to receive fulvestrant

9. Adequate bone marrow and organ function

Exclusion Criteria:

1. 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

2. 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

3. Moderate liver impairment which would require a reduced dose of fulvestrant

4. 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

5. Known allergy or hypersensitivity to fulvestrant

6. For Phase 2 only: prior therapy with fulvestrant and/or investigational ER targeted agent

7. Females who are pregnant or breast feeding

Related Conditions & MeSH terms

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

Intervention

Drug:
• NUV-422
NUV-422 is an investigational drug for oral dosing.
• Fulvestrant
Fulvestrant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nuvation Bio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with fulvestrant to determine the recommended Phase 2 combination dose (RP2cD)	Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities	During the DLT period (28 days)
Primary	Phase 2 Dose Expansion: Objective Response Rate (ORR)	ORR per standard criteria	Every 8 weeks through study treatment, an average of 6 months