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Undersøgelse af REGN5678 (Anti-PSMAxCD28) med Cemiplimab (Anti-PD-1) hos patienter med metastatisk kastrationsresistent prostatakræft

3. november 2026 opdateret af: Regeneron Pharmaceuticals

Et fase 1/2-studie af REGN5678 (Anti-PSMAxCD28) med Cemiplimab (Anti-PD-1) hos patienter med metastatisk kastrationsresistent prostatakræft

The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug[s]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.

The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.

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

  1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab
  2. How REGN5678 alone or in combination with cemiplimab works in the body
  3. How much REGN5678 and/or cemiplimab are present in the blood
  4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

345

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85234
        • Rekruttering
        • Banner MD Anderson Cancer Center
      • Phoenix, Arizona, Forenede Stater, 85054
        • Rekruttering
        • Mayo Clinic
      • Tucson, Arizona, Forenede Stater, 85724
        • Rekruttering
        • University of Arizona
    • California
      • Santa Monica, California, Forenede Stater, 90404
        • Rekruttering
        • John Wayne Cancer Institute (JWCI)
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Rekruttering
        • Sarah Cannon Research Institute (SCRI)
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Rekruttering
        • Yale University Hospital
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Rekruttering
        • Mayo Clinic Jacksonville
      • Tampa, Florida, Forenede Stater, 33612
        • Rekruttering
        • Moffitt Cancer Center - McKinley Drive
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Rekruttering
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Rekruttering
        • Henry Ford Health
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Rekruttering
        • Mayo Clinic
    • New York
      • New York, New York, Forenede Stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forenede Stater, 10461
        • Rekruttering
        • Montefiore Medical Center
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • NYU Langone Health Perlmutter Cancer Center
      • New York, New York, Forenede Stater, 10032
        • Rekruttering
        • Columbia University - The Trustees of Columbia University in the City of New York
      • Rochester, New York, Forenede Stater, 14642
        • Rekruttering
        • University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • James Cancer Hospital and Solove Research Institute
    • Oregon
      • Portland, Oregon, Forenede Stater, 97213
        • Trukket tilbage
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97239
        • Rekruttering
        • Oregon Health & Science University (3485 S. Bond)
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Rekruttering
        • Thomas Jefferson University Hospital
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rekruttering
        • Lifespan Cancer Institute
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Rekruttering
        • Emily Couric Clinical Cancer Center
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • Rekruttering
        • West Virginia University
  • Sydkorea
      • Seoul, Sydkorea, 05505
        • Rekruttering
        • Asan Medical Center
      • Seoul, Sydkorea, 03722
        • Rekruttering
        • Yonsei University - Severance Hospital - Colorectal Cancer Clinic
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Sydkorea, 16247
        • Rekruttering
        • The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

mCRPC cohorts (men):

  1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.

  2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.

  3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy [ADT]) including at least:

    1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
    2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol

ccRCC cohorts (men and women):

  1. Histologically or cytologically confirmed RCC with a clear-cell component.
  2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria
  3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) [PD-1]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor

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, as described in the protocol
  2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol
  3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC
  4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.
  5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol
  6. 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
  7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol
  8. 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
  9. 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: mCRPC - dose escalation cohort

REGN5678 with or without cemiplimab
Medicin: REGN5678

Administered as per the protocol

Andre navne:
  • Nezastomig
Medicin: Cemiplimab

Administered as per the protocol

Andre navne:
  • REGN2810
  • LIBTAYO
Eksperimentel: mCRPC - dose expansion cohort

REGN5678 with or without cemiplimab
Medicin: REGN5678

Administered as per the protocol

Andre navne:
  • Nezastomig
Eksperimentel: ccRCC - dose escalation cohort

REGN5678 with or without cemiplimab
Medicin: REGN5678

Administered as per the protocol

Andre navne:
  • Nezastomig
Medicin: Cemiplimab

Administered as per the protocol

Andre navne:
  • REGN2810
  • LIBTAYO
Eksperimentel: ccRCC - dose expansion cohort

REGN5678 with or without cemiplimab
Medicin: REGN5678

Administered as per the protocol

Andre navne:
  • Nezastomig

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Adverse Event of Special Interests (AESIs)
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Number of participants with Grade ≥3 laboratory abnormalities
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence of Dose-Limiting Toxicities (DLTs)
Tidsramme: First dose through day 42 of last participant in each dose level

Dose Escalation Phase
First dose through day 42 of last participant in each dose level
Concentration of REGN5678 in serum over time
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase - mCRPC cohort
Through study completion, up to 5 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase - ccRCC cohort
Through study completion, up to 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase - mCRPC cohort
Through study completion, up to 5 years
ORR per RECIST 1.1 criteria
Tidsramme: Through study completion, up to 5 years

Dose Escalation Phase - ccRCC cohort
Through study completion, up to 5 years
Incidence and severity of TEAEs
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of AESIs
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Incidence and severity of SAEs
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Number of participants with grade ≥3 laboratory abnormalities
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in serum over time
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Concentration of REGN5678 in combination with cemiplimab in serum over time
Tidsramme: Through study completion, up to 5 years

Dose Expansion Phase
Through study completion, up to 5 years
Percentage of participants with ≥50% decline of PSA
Tidsramme: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases - mCRPC cohorts
Through study completion, up to 5 years
Percentage of participants with ≥90% decline of PSA
Tidsramme: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases- mCRPC cohorts
Through study completion, up to 5 years
Presence or absence of antibodies against REGN5678
Tidsramme: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 years
Presence or absence of antibodies against cemiplimab
Tidsramme: Through study completion, up to 5 years

Dose Escalation and Dose Expansion Phases
Through study completion, up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Efterforskere

  • Studieleder: Clinical Trials Management, Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. august 2019

Primær færdiggørelse (Anslået)

15. november 2027

Studieafslutning (Anslået)

15. november 2027

Datoer for studieregistrering

Først indsendt

30. maj 2019

Først indsendt, der opfyldte QC-kriterier

30. maj 2019

Først opslået (Faktiske)

3. juni 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R5678-ONC-1879

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All individual patient data (IPD) that underlie publicly available results will be considered for sharing

IPD-delingstidsramme

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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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