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REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma

9. september 2026 oppdatert av: Regeneron Pharmaceuticals

Phase 1/2 Study of REGN15505 (a PSMAx4-1BB Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN4336 (a PSMAxCD3 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma

This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells.

The study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for:

  • Any side effects of study drugs
  • How well the study drugs work
  • How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times
  • If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected
  • What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

265

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Arizona
      • Goodyear, Arizona, Forente stater, 85338
        • Rekruttering
        • City of Hope Phoenix
    • California
      • Duarte, California, Forente stater, 91010
        • Rekruttering
        • City of Hope
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • Rekruttering
        • H. Lee Moffitt Cancer Center
    • Illinois
      • Zion, Illinois, Forente stater, 60099
        • Rekruttering
        • City of Hope Chicago, City of Hope Cancer Center Chicago
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • The University of Texas MD Anderson Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Key Inclusion Criteria:

Participants with mCRPC:

  1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
  2. mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
  3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol

  4. Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone <50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study

    Participants with ccRCC:

  5. Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
  6. Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
  7. Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)/ Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and/or a Tyrosine Kinase Inhibitor (TKI)

Key Exclusion Criteria:

For Both mCRPC and ccRCC Cohorts:

  1. Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in the protocol

    mCRPC Cohort Only:

  2. Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617)

Note: Other protocol defined inclusion/exclusion criteria apply

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Module 1: Monotherapy
REGN15505
Legemiddel: REGN15505
Administered per protocol
Eksperimentell: Module 2: Combination 1
REGN15505 and Cemiplimab
Legemiddel: REGN15505+Cemiplimab
Administered per protocol
Andre navn:
  • REGN2810
  • Libtayo
Eksperimentell: Module 3: Combination 2
REGN15505 and REGN4336
Legemiddel: REGN15505+REGN4336
Administered per protocol

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Occurrence of Dose Limiting Toxicities (DLTs)
Tidsramme: Up to 5 years
Dose Escalation
Up to 5 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to 5 years
Dose Escalation
Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
Tidsramme: Up to 5 years
Dose Escalation
Up to 5 years
Occurrence of Adverse Events of Special Interest (AESIs)
Tidsramme: Up to 5 years
Dose Escalation
Up to 5 years
Composite Response (CompR) based on ≥50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic assessment of complete response (CR) or partial response (PR)
Tidsramme: Up to 5 years
Dose Expansion-mCRPC
Up to 5 years
Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Tidsramme: Up to 5 years
Dose Expansion-ccRCC
Up to 5 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
CompR based on ≥50% decline of PSA from baseline and/or confirmed radiographic assessment of CR or PR
Tidsramme: Up to 5 years
Dose Escalation-mCRPC
Up to 5 years
Percentage of participants with ≥50% reduction of PSA
Tidsramme: Up to 5 years
Dose Escalation and Dose Expansion Phases - mCRPC cohorts
Up to 5 years
Percentage of participants with ≥90% reduction in PSA
Tidsramme: Up to 5 years
Dose Escalation and Dose Expansion - mCRPC cohorts
Up to 5 years
Concentration of REGN15505 in serum
Tidsramme: Up to 5 years
Dose Escalation and Expansion
Up to 5 years
Occurrence of Anti Drug Antibodies (ADA) against REGN15505
Tidsramme: Up to 5 years
Dose Escalation and Expansion
Up to 5 years
Occurrence of ADA against REGN4336
Tidsramme: Up to 5 years
Dose Escalation and Expansion
Up to 5 years
Magnitude of ADA against REGN15505
Tidsramme: Up to 5 years
Dose Escalation and Expansion
Up to 5 years
Magnitude of ADA against REGN4336
Tidsramme: Up to 5 years
Dose Escalation and Expansion
Up to 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Etterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. juli 2026

Primær fullføring (Antatt)

27. oktober 2030

Studiet fullført (Antatt)

27. oktober 2030

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R15505-ONC-24144

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere