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

July 10, 2023 updated by: Nuvation Bio Inc.

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc.
      • Fountain Valley, California, United States, 92708
        • Compassionate Cancer Care Research Inc.
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center Research
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Pennsylvania Cancer Specialists and Research Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Next Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.
Drug: Fulvestrant
Fulvestrant
Other Names:
  • Faslodex
Experimental: 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.
Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.
Drug: Fulvestrant
Fulvestrant
Other Names:
  • Faslodex
Experimental: Phase 2 NUV-422 monotherapy
NUV-422 will be administered orally at the RP2cD.
Drug: NUV-422
NUV-422 is an investigational drug for oral dosing.
Experimental: 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.
Drug: Fulvestrant
Fulvestrant
Other Names:
  • Faslodex

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvation Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUV-422-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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