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Studio di REGN5678 (Anti-PSMAxCD28) con Cemiplimab (Anti-PD-1) in pazienti con carcinoma prostatico metastatico resistente alla castrazione

3 novembre 2026 aggiornato da: Regeneron Pharmaceuticals

Uno studio di fase 1/2 su REGN5678 (Anti-PSMAxCD28) con Cemiplimab (Anti-PD-1) in pazienti con carcinoma prostatico metastatico resistente alla castrazione

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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

345

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: mCRPC - dose escalation cohort

REGN5678 with or without cemiplimab
Droga: REGN5678

Administered as per the protocol

Altri nomi:
  • Nezastomig
Droga: Cemiplimab

Administered as per the protocol

Altri nomi:
  • REGN2810
  • LIBTAIO
Sperimentale: mCRPC - dose expansion cohort

REGN5678 with or without cemiplimab
Droga: REGN5678

Administered as per the protocol

Altri nomi:
  • Nezastomig
Sperimentale: ccRCC - dose escalation cohort

REGN5678 with or without cemiplimab
Droga: REGN5678

Administered as per the protocol

Altri nomi:
  • Nezastomig
Droga: Cemiplimab

Administered as per the protocol

Altri nomi:
  • REGN2810
  • LIBTAIO
Sperimentale: ccRCC - dose expansion cohort

REGN5678 with or without cemiplimab
Droga: REGN5678

Administered as per the protocol

Altri nomi:
  • Nezastomig

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Through study completion, up to 5 years

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

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR
Lasso di tempo: 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
Lasso di tempo: Through study completion, up to 5 years

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

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

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

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

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Regeneron Pharmaceuticals

Investigatori

  • Direttore dello studio: Clinical Trials Management, Regeneron Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 agosto 2019

Completamento primario (Stimato)

15 novembre 2027

Completamento dello studio (Stimato)

15 novembre 2027

Date di iscrizione allo studio

Primo inviato

30 maggio 2019

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2019

Primo Inserito (Effettivo)

3 giugno 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R5678-ONC-1879

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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