A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer

Last updated: April 8, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1/2

Condition

Prostate Cancer

Urologic Cancer

Prostate Disorders

Treatment

Cemiplimab

REGN5678

18F-DCFPyL

Clinical Study ID

NCT05125016
R4336-ONC-20104
2022-502130-17-00
  • Ages > 18
  • Male

Study Summary

This study is researching an investigational drug called REGN4336. Some participants may receive additional investigational drugs in combination with REGN4336. These additional drugs include REGN5678, cemiplimab and sarilumab.

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug) and effectiveness of REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678. REGN4336, cemiplimab and REGN5678 are a type of treatment for cancer called immunotherapy,and are intended to activate T-cells to attack cancer cells.

This study has 2 parts. The purpose of Part 1 is to determine a safe dose of REGN4336 when given alone or when given in combination with cemiplimab or REGN5678. The purpose of Part 2 is to use the REGN4336 dose(s) determined in Part 1 to further test how well REGN4336 works to shrink tumors either when given alone or in combination with cemiplimab or REGN5678.

This study is looking at several other research questions, including:

  • What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678?

  • How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678?

  • Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate withoutpure small cell carcinoma

  2. Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening, according to 1 ofthe following:

  3. PSA progression as defined by a rising PSA level confirmed with an interval of ≥1 week between each assessment

  4. Radiographic disease progression in soft tissue based on Response EvaluationCriteria in Solid Tumors (RECIST) version 1.1 criteria with or without PSAprogression

  5. Radiographic disease progression in bone defined as the appearance of 2 or morenew bone lesions on bone scan with or without PSA progression NOTE: Measurabledisease per RECIST version 1.1 per local reading at screening is not aneligibility criterion for enrollment

  6. Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in themetastatic and/or castration-resistant setting (in addition to androgen deprivationtherapy [ADT]) including at least one second-generation anti-androgen therapy (e.g.abiraterone, enzalutamide, apalutamide, or darolutamide)

Exclusion

Key Exclusion Criteria:

  1. Has received treatment with an approved systemic therapy within 3 weeks of dosing orhas not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities

  2. Has received any previous systemic biologic or immune-modulating therapy (except forSipuleucel-T) within 5 half-lives of first dose of study therapy, as described inthe protocol

  3. Has received prior PSMA-targeting therapy. Exception: Prior therapy with approvedPSMA-targeted radioligand(s) is permitted

  4. Any condition that requires ongoing/continuous corticosteroid therapy (>10 mgprednisone/day or anti-inflammatory equivalent) within 1 week prior to the firstdose of study therapy

  5. Ongoing or recent (within 5 years) evidence of significant autoimmune disease thatrequired treatment with systemic immunosuppressive treatments

  6. Encephalitis, meningitis, neurodegenerative disease (with the exception of milddementia that does not interfere with activities of daily living [ADLs]) oruncontrolled seizures in the year prior to first dose of study therapy

  7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B orhepatitis C infection; or diagnosis of immunodeficiency, as described in theprotocol.

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study Design

Total Participants: 370
Treatment Group(s): 5
Primary Treatment: Cemiplimab
Phase: 1/2
Study Start date:
November 30, 2021
Estimated Completion Date:
January 14, 2027

Connect with a study center

  • Stanford Cancer Center

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Stanford University Medical Center - Blake Wilbur Drive

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Atrium Health Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The Ohio State University James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Active - Recruiting

  • Penn Medicine University of Pennsylvania Health System

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Thomas Jefferson University, Sidney Kimmel Center, Clinical Research Organization

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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