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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 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

265

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

Studiesteder

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

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

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
REGN15505
Medicin: REGN15505
Administered per protocol
Eksperimentel: Module 2: Combination 1
REGN15505 and Cemiplimab
Medicin: REGN15505+Cemiplimab
Administered per protocol
Andre navne:
  • REGN2810
  • Libtayo
Eksperimentel: Module 3: Combination 2
REGN15505 and REGN4336
Medicin: REGN15505+REGN4336
Administered per protocol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

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 (Faktiske)

20. juli 2026

Primær færdiggørelse (Anslået)

27. oktober 2030

Studieafslutning (Anslået)

27. oktober 2030

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R15505-ONC-24144

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner