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REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants

23. September 2026 aktualisiert von: Regeneron Pharmaceuticals

Phase 1/2 Trial of REGN21353 (a STEAP1xCD3 Bispecific Antibody) Administered Alone or in Combination With Nezastomig (a PSMAxCD28 Bispecific Antibody) in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This study will test an experimental Regeneron drug called REGN21353 ("study drug") to see if it can help treat previously treated prostate cancer that has spread (also called metastatic castration-resistant prostate cancer or mCRPC). Some participants may get additional experimental drugs in combination with REGN21353. These additional drugs are nezastomig and sarilumab. "Experimental" means that the drugs are being tested and have not been approved for use in prostate cancer by a country's national health agency that gives approval for new medicines to be prescribed.

The study is looking at:

  • What is the best dose of REGN21353 alone and together with nezastomig for treating prostate cancer
  • What side effects REGN21353 alone and together with nezastomig might cause
  • How well REGN21353 alone and together with nezastomig works
  • How much REGN21353 alone and together with nezastomig is in the blood at different times
  • If the body reacts to REGN21353 alone or together with nezastomig, in a way that may cause them to not work as well
  • How REGN21353 alone and together with nezastomig could affect prostate cancer, which can help researchers understand why REGN21353 alone or together with nezastomig work better in some than others

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

192

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

Key Inclusion Criteria:

  1. Is male with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
  2. Has metastatic castration-resistant prostate cancer with prostate-specific antigen value as described in the protocol and that has progressed within 6 months prior to screening
  3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy) including at least one androgen receptor pathway inhibitor (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)
  4. Has had either orchiectomy or be on luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy with serum testosterone levels as described in the protocol and agree to stay on LHRH agonist or antagonist therapy during the trial
  5. Is able and willing to provide tumor tissue, either archival or newly obtained
  6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  7. Has adequate organ, bone marrow, renal and hepatic function

Key Exclusion Criteria:

  1. Has not recovered (ie, grade ≤1 or baseline) from immune-mediated adverse event within 3 months prior to initiation of trial intervention therapy except for endocrinopathies adequately managed with hormone replacement
  2. Has permanently discontinued anti-cancer immune modulating therapies due to immune-mediated adverse events
  3. Has another malignancy that is progressing or requires active treatment, except non-melanoma skin cancer that has undergone potentially curative therapy or any tumor that has been deemed to be effectively treated with definitive local control
  4. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease (including any history of systemic vasculitis) that required treatment with systemic immunosuppressive treatments
  5. Has active liver metastases
  6. Has current evidence of or history of central nervous system metastases as described in the protocol
  7. Has encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living), or uncontrolled seizures in the year prior to first dose of trial intervention
  8. Has a known history of, or any evidence of, interstitial lung disease or active, noninfectious pneumonitis (past 5 years). A history of radiation pneumonitis in the radiation field is permitted
  9. Has active or recent infection requiring hospitalization or treatment with intravenous anti-infectives within 2 weeks of first dose of trial intervention
  10. Has significant cardiovascular disease

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Module 1: monotherapy
Arzneimittel: REGN21353

Administered per the protocol

Arzneimittel: Sarilumab Prophylaxis (Contingency)

May be administered as pretreatment, per the protocol

Andere Namen:
  • SAR153191
  • REG88
  • KEVZARA®
Experimental: Module 2: combination
Arzneimittel: REGN21353

Administered per the protocol

Arzneimittel: Sarilumab Prophylaxis (Contingency)

May be administered as pretreatment, per the protocol

Andere Namen:
  • SAR153191
  • REG88
  • KEVZARA®
Arzneimittel: Nezastomig

Administered per the protocol

Andere Namen:
  • REGN5678

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: Up to 5 years

Dose escalation
Up to 5 years
Occurrence of Dose-Limiting Toxicities (DLTs)
Zeitfenster: Up to 42 days

Dose escalation
Up to 42 days
Occurrence of Serious Adverse Events (SAEs)
Zeitfenster: Up to 5 years

Dose escalation
Up to 5 years
Occurrence of Adverse Events of Special Interests (AESIs)
Zeitfenster: Up to 5 years

Dose escalation
Up to 5 years
Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
Zeitfenster: Up to 5 years

Dose expansion
Up to 5 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
(CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
Zeitfenster: Up to 5 years

Dose escalation
Up to 5 years
Occurrence of TEAEs
Zeitfenster: Up to 5 years

Dose expansion
Up to 5 years
Occurrence of SAEs
Zeitfenster: Up to 5 years

Dose expansion
Up to 5 years
Occurrence of AESIs
Zeitfenster: Up to 5 years

Dose expansion
Up to 5 years
Percentage of participants with ≥50% reduction in PSA confirmed by a second PSA test ≥3 weeks later
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years
Percentage of participants with ≥90% reduction in PSA confirmed by a second PSA test ≥3 weeks later
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years
REGN21353 serum concentrations
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years
Nezastomig serum concentrations
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years
Occurrence of Anti-Drug Antibodies (ADA) to REGN21353
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years
Occurrence of ADA to nezastomig
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years
Magnitude of ADA to REGN21353
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years
Magnitude of ADA to nezastomig
Zeitfenster: Up to 5 years

Dose Escalation and Dose Expansion
Up to 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Regeneron Pharmaceuticals

Ermittler

  • Studienleiter: Clinical Trial Management, Regeneron Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

28. Juni 2027

Primärer Abschluss (Geschätzt)

28. Juli 2031

Studienabschluss (Geschätzt)

28. Juli 2031

Studienanmeldedaten

Zuerst eingereicht

23. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2026

Zuerst gepostet (Tatsächlich)

30. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R21353-ONC-25105

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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