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Studie av REGN5678 (Anti-PSMAxCD28) med Cemiplimab (Anti-PD-1) hos patienter med metastaserad kastrationsresistent prostatacancer

3 november 2026 uppdaterad av: Regeneron Pharmaceuticals

En fas 1/2-studie av REGN5678 (Anti-PSMAxCD28) med Cemiplimab (Anti-PD-1) hos patienter med metastaserad kastrationsresistent prostatacancer

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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

345

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: mCRPC - dose escalation cohort

REGN5678 with or without cemiplimab
Läkemedel: REGN5678

Administered as per the protocol

Andra namn:
  • Nezastomig
Läkemedel: Cemiplimab

Administered as per the protocol

Andra namn:
  • REGN2810
  • LIBTAYO
Experimentell: mCRPC - dose expansion cohort

REGN5678 with or without cemiplimab
Läkemedel: REGN5678

Administered as per the protocol

Andra namn:
  • Nezastomig
Experimentell: ccRCC - dose escalation cohort

REGN5678 with or without cemiplimab
Läkemedel: REGN5678

Administered as per the protocol

Andra namn:
  • Nezastomig
Läkemedel: Cemiplimab

Administered as per the protocol

Andra namn:
  • REGN2810
  • LIBTAYO
Experimentell: ccRCC - dose expansion cohort

REGN5678 with or without cemiplimab
Läkemedel: REGN5678

Administered as per the protocol

Andra namn:
  • Nezastomig

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: Through study completion, up to 5 years

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

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
Tidsram: 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
Tidsram: Through study completion, up to 5 years

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

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

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

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Regeneron Pharmaceuticals

Utredare

  • Studierektor: Clinical Trials Management, Regeneron Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 augusti 2019

Primärt slutförande (Beräknad)

15 november 2027

Avslutad studie (Beräknad)

15 november 2027

Studieregistreringsdatum

Först inskickad

30 maj 2019

Först inskickad som uppfyllde QC-kriterierna

30 maj 2019

Första postat (Faktisk)

3 juni 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • R5678-ONC-1879

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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