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Studie van REGN5678 (Anti-PSMAxCD28) met cemiplimab (Anti-PD-1) bij patiënten met gemetastaseerde castratieresistente prostaatkanker

3 november 2026 bijgewerkt door: Regeneron Pharmaceuticals

Een fase 1/2-studie van REGN5678 (anti-PSMAxCD28) met cemiplimab (anti-PD-1) bij patiënten met gemetastaseerde castratieresistente prostaatkanker

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

345

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: mCRPC - dose escalation cohort

REGN5678 with or without cemiplimab
Geneesmiddel: REGN5678

Administered as per the protocol

Andere namen:
  • Nezastomig
Geneesmiddel: Cemiplimab

Administered as per the protocol

Andere namen:
  • REGN2810
  • LIBTAYO
Experimenteel: mCRPC - dose expansion cohort

REGN5678 with or without cemiplimab
Geneesmiddel: REGN5678

Administered as per the protocol

Andere namen:
  • Nezastomig
Experimenteel: ccRCC - dose escalation cohort

REGN5678 with or without cemiplimab
Geneesmiddel: REGN5678

Administered as per the protocol

Andere namen:
  • Nezastomig
Geneesmiddel: Cemiplimab

Administered as per the protocol

Andere namen:
  • REGN2810
  • LIBTAYO
Experimenteel: ccRCC - dose expansion cohort

REGN5678 with or without cemiplimab
Geneesmiddel: REGN5678

Administered as per the protocol

Andere namen:
  • Nezastomig

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Through study completion, up to 5 years

Dose Escalation Phase
Through study completion, up to 5 years
Incidence of Dose-Limiting Toxicities (DLTs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Through study completion, up to 5 years

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
Tijdsspanne: 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
Tijdsspanne: Through study completion, up to 5 years

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

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

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

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Regeneron Pharmaceuticals

Onderzoekers

  • Studie directeur: Clinical Trials Management, Regeneron Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 augustus 2019

Primaire voltooiing (Geschat)

15 november 2027

Studie voltooiing (Geschat)

15 november 2027

Studieregistratiedata

Eerst ingediend

30 mei 2019

Eerst ingediend dat voldeed aan de QC-criteria

30 mei 2019

Eerst geplaatst (Werkelijk)

3 juni 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R5678-ONC-1879

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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