Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC

Sponsor
Nuvation Bio Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05191017
Collaborator
(none)
76
2
51

Study Details

Study Description

Brief Summary

NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1b/2 Safety and Efficacy Study of NUV-422 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1b Dose Escalation

NUV-422 will be administered orally at escalating dose levels in combination with enzalutamide until the recommended Phase 2 combination dose (RP2cD) is determined. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

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

Drug: Enzalutamide
Enzalutamide
Other Names:
  • Xtandi
  • Experimental: Phase 2

    NUV-422 will be administered orally at the RP2cD in combination with enzalutamide. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-422.

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

    Drug: Enzalutamide
    Enzalutamide
    Other Names:
  • Xtandi
  • Outcome Measures

    Primary Outcome Measures

    1. Phase 1b Dose Escalation: Safety and tolerability of NUV-422 in combination with enzalutamide to determine the recommended Phase 2 combination dose (RP2cD) [During the DLT period (28 days)]

      Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and laboratory abnormalities

    2. Phase 2 Dose Expansion: Prostate-specific antigen (PSA)-response rate (PSA-RR) [Every 4 weeks throughout study treatment, an average of 6 months]

      PSA per standard criteria

    3. Phase 2 Dose Expansion: Objective response rate (ORR) [Every 8 weeks throughout study treatment, an average of 6 months]

      ORR per standard criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone

    2. Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria

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

    4. Prior therapy with abiraterone required and:

    • For Phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease

    • For Phase 2 only: Patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with CDK inhibitors

    1. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2

    2. Adequate bone marrow and organ function

    3. Eligible to receive enzalutamide

    4. Life expectancy of > 6 months

    Exclusion Criteria:
    1. History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)

    2. Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide

    3. Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or < 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422 and enzalutamide

    4. Requires medications that are known to be strong inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide

    • For Phase 1b only: Requires medications that are known to be moderate inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
    1. Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors

    2. Known allergy or hypersensitivity to enzalutamide

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nuvation Bio Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nuvation Bio Inc.
    ClinicalTrials.gov Identifier:
    NCT05191017
    Other Study ID Numbers:
    • NUV-422-04
    First Posted:
    Jan 13, 2022
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nuvation Bio Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2022