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

NCT ID: NCT05191004

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b Dose Escalation

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.

Group Type: EXPERIMENTAL

NUV-422

Intervention Type: DRUG

NUV-422 is an investigational drug for oral dosing.

Fulvestrant

Intervention Type: DRUG

Fulvestrant

Phase 2 NUV-422 + fulvestrant

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.

Group Type: EXPERIMENTAL

NUV-422

Intervention Type: DRUG

NUV-422 is an investigational drug for oral dosing.

Fulvestrant

Intervention Type: DRUG

Fulvestrant

Phase 2 NUV-422 monotherapy

NUV-422 will be administered orally at the RP2cD.

Group Type: EXPERIMENTAL

NUV-422

Intervention Type: DRUG

NUV-422 is an investigational drug for oral dosing.

Phase 2 fulvestrant monotherapy

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

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

Fulvestrant

Interventions

NUV-422

NUV-422 is an investigational drug for oral dosing.

Intervention Type: DRUG

Fulvestrant

Fulvestrant

Intervention Type: DRUG

Other Intervention Names

Faslodex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuvation Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

NUV-422-03

Identifier Type: -

Identifier Source: org_study_id