REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants
23. september 2026 opdateret af: 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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
192
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
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
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
Han
Beskrivelse
Key Inclusion Criteria:
- Is male with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
- 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
- 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)
- 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
- Is able and willing to provide tumor tissue, either archival or newly obtained
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has adequate organ, bone marrow, renal and hepatic function
Key Exclusion Criteria:
- 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
- Has permanently discontinued anti-cancer immune modulating therapies due to immune-mediated adverse events
- 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
- 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
- Has active liver metastases
- Has current evidence of or history of central nervous system metastases as described in the protocol
- 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
- 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
- Has active or recent infection requiring hospitalization or treatment with intravenous anti-infectives within 2 weeks of first dose of trial intervention
- Has significant cardiovascular disease
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: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Module 1: monotherapy
|
Administered per the protocol May be administered as pretreatment, per the protocol
Andre navne:
|
|
Eksperimentel: Module 2: combination
|
Administered per the protocol May be administered as pretreatment, per the protocol
Andre navne:
Administered per the protocol
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to 5 years
|
Dose escalation |
Up to 5 years
|
|
Occurrence of Dose-Limiting Toxicities (DLTs)
Tidsramme: Up to 42 days
|
Dose escalation |
Up to 42 days
|
|
Occurrence of Serious Adverse Events (SAEs)
Tidsramme: Up to 5 years
|
Dose escalation |
Up to 5 years
|
|
Occurrence of Adverse Events of Special Interests (AESIs)
Tidsramme: 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)
Tidsramme: Up to 5 years
|
Dose expansion |
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
(CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
Tidsramme: Up to 5 years
|
Dose escalation |
Up to 5 years
|
|
Occurrence of TEAEs
Tidsramme: Up to 5 years
|
Dose expansion |
Up to 5 years
|
|
Occurrence of SAEs
Tidsramme: Up to 5 years
|
Dose expansion |
Up to 5 years
|
|
Occurrence of AESIs
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
REGN21353 serum concentrations
Tidsramme: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Nezastomig serum concentrations
Tidsramme: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Occurrence of Anti-Drug Antibodies (ADA) to REGN21353
Tidsramme: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Occurrence of ADA to nezastomig
Tidsramme: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Magnitude of ADA to REGN21353
Tidsramme: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
|
Magnitude of ADA to nezastomig
Tidsramme: Up to 5 years
|
Dose Escalation and Dose Expansion |
Up to 5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trial 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 (Anslået)
28. juni 2027
Primær færdiggørelse (Anslået)
28. juli 2031
Studieafslutning (Anslået)
28. juli 2031
Datoer for studieregistrering
Først indsendt
23. september 2026
Først indsendt, der opfyldte QC-kriterier
23. september 2026
Først opslået (Faktiske)
30. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Metastatisk prostatacancer
- Prostatakræft
- Luteiniserende hormon-frigivende hormon (LHRH)
- Hormonrefraktær prostatacancer
- Avanceret prostatakræft
- Androgen deprivationsterapi (ADT)
- Kastrationsresistent prostatacancer
- Androgen-uafhængig prostatacancer
- PSA progression
- Stage 4 prostate cancer
- Prostate cancer that has spread
- Androgen-resistant prostate cancer
- Androgen receptor pathway inhibitor (ARPI)
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R21353-ONC-25105
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
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