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REGN4336 (a PSMAXCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Adult Male Patients With Metastatic Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT05125016
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is:

Dose Escalation:

• To assess the safety, tolerability, and pharmacokinetics (PK) and to determine recommended phase 2 dosing regimen (RP2DR) of REGN4336 separately as monotherapy or in combination with cemiplimab

Dose Expansion:

• To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by objective response rate (ORR) per modified Prostate Cancer Working Group (PCWG3) criteria

The secondary objectives of the study are:

Dose Escalation:

• To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by ORR per modified PCWG3 criteria

Dose Expansion:

  • To characterize the safety profile in each expansion cohort
  • To characterize the PK of REGN4336 as monotherapy or in combination with cemiplimab

In both Dose Escalation and Dose Expansion:

  • To assess preliminary anti-tumor activity of REGN4336 as monotherapy or in combination with cemiplimab as measured by prostate specific antigen (PSA) decline
  • To evaluate immunogenicity of REGN4336 in Module 1 and immunogenicity of REGN4336 and cemiplimab in Module 2

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: REGN4336 Drug: Cemiplimab Other: 18F-DCFPyL Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 199 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study contains 2 separate modules in parallel: monotherapy with REGN4336 (Module 1) and combination therapy with REGN4336 and cemiplimab (Module 2). Both modules contain independent dose escalation cohorts and up to 2 recommended phase 2 dose regimens during dose expansion.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of REGN4336 (a PSMAXCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : August 4, 2026
Estimated Study Completion Date : August 4, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Module 1- Monotherapy
REGN4336
Drug: REGN4336
Administered once weekly (QW) or every 3 weeks (Q3W) by subcutaneous (SC) injection.

Other: 18F-DCFPyL
Prostate-specific membrane antigen (PSMA) Positron emission tomography (PET)/Computer tomography (CT) imaging agent to be used at select sites

Experimental: Module 2-Combo Therapy
REGN4336 + Cemiplimab
Drug: REGN4336
Administered once weekly (QW) or every 3 weeks (Q3W) by subcutaneous (SC) injection.

Drug: Cemiplimab
Administered concomitantly every 3 weeks (Q3W) by IV infusion
Other Names:
  • REGN2810
  • Libtayo

Other: 18F-DCFPyL
Prostate-specific membrane antigen (PSMA) Positron emission tomography (PET)/Computer tomography (CT) imaging agent to be used at select sites




Primary Outcome Measures :
  1. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 days, up to 42 days ]
    Dose escalation

  2. Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 5 years ]
    Dose escalation

  3. Incidence and severity of Immune-related Adverse Events (irAEs) [ Time Frame: Up to 5 years ]
    Dose escalation

  4. Incidence and severity of SAEs [ Time Frame: Up to 5 years ]
    Dose escalation

  5. Incidence and severity of adverse event of special interests (AESIs) [ Time Frame: Up to 5 years ]
    Dose escalation

  6. Number of patients with grade ≥3 laboratory abnormalities [ Time Frame: Up to 5 years ]
    Dose escalation

  7. REGN4336 concentrations in serum [ Time Frame: Up to 5 years ]

    Dose escalation:

    As monotherapy or in combination with cemiplimab


  8. ORR per modified per modified Prostate Cancer Working Group 3 (PCWG3) criteria [ Time Frame: Up to 5 years ]
    Dose expansion


Secondary Outcome Measures :
  1. ORR per modified per modified PCWG3 criteria [ Time Frame: Up to 5 years ]
    Dose Escalation:

  2. Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
    Dose expansion

  3. Incidence and severity of TEAEs [ Time Frame: Up to 5 years ]
    Dose expansion

  4. Incidence and severity of Immune-related Adverse Events [ Time Frame: Up to 5 years ]
    Dose expansion

  5. Incidence and severity of SAEs [ Time Frame: Up to 5 years ]
    Dose expansion

  6. Incidence and severity of adverse event of special interests (AESIs) [ Time Frame: Up to 5 years ]
    Dose expansion

  7. Number of patients with grade ≥3 laboratory abnormalities [ Time Frame: Up to 5 years ]
    Dose expansion

  8. REGN4336 concentrations in serum [ Time Frame: Up to 5 years ]

    Dose expansion:

    As monotherapy or in combination with cemiplimab


  9. Percentage of patients with ≥50% reduction prostate specific antigen (PSA) from baseline, confirmed by a second PSA test ≥4 weeks later [ Time Frame: Up to 5 years ]
    Dose escalation and expansion

  10. Percentage of patients with ≥90% reduction prostate specific antigen (PSA) from baseline, confirmed by a second PSA test ≥4 weeks later [ Time Frame: UP to 5 years ]
    Dose escalation and expansion

  11. Anti-drug antibodies (ADA) to REGN4336 [ Time Frame: Up to 5 years ]
    Module 1

  12. ADA to REGN4336 and cemiplimab [ Time Frame: Up to 5 years ]
    Module 2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure 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 as defined in the protocol
  3. Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy [ADT]) including at least one second-generation anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)

Key Exclusion Criteria:

  1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities
  2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy
  3. Has received prior PSMA-targeting therapy
  4. Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
  5. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
  6. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living [ADLs]) or uncontrolled seizures in the year prior to first dose of study therapy
  7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05125016


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, California
Stanford Cancer Center Recruiting
Palo Alto, California, United States, 94304
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
United States, Maryland
University of Maryland, Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
United States, Pennsylvania
University of Pennsylvania Perelman Center for Advanced Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University, Sidney Kimmel Center, Clinical Research Organization Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Wisconsin
Froedtert and Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05125016    
Other Study ID Numbers: R4336-ONC-20104
2021-001104-15 ( EudraCT Number )
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Treatment-experienced metastatic castration-resistant prostate cancer (mCRPC)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents