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
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
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Studiesteder
-
-
Arizona
-
Goodyear, Arizona, Forenede Stater, 85338
- Rekruttering
- City of Hope Phoenix
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-
California
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Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope
-
-
Florida
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- H. Lee Moffitt Cancer Center
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-
Illinois
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Zion, Illinois, Forenede Stater, 60099
- Rekruttering
- City of Hope Chicago, City of Hope Cancer Center Chicago
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University
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Texas
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- The University of Texas MD Anderson Cancer Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Key Inclusion Criteria:
Participants with mCRPC:
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Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
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mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
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Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
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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:
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Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
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Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
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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:
-
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:
-
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
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 |
Administered per protocol |
|
Eksperimentel: Module 2: Combination 1
REGN15505 and Cemiplimab |
Administered per protocol
Andre navne:
|
|
Eksperimentel: Module 3: Combination 2
REGN15505 and 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
Sponsor
Efterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Urologiske neoplasmer
- Karcinom
- Nyre-neoplasmer
- Karcinom, nyrecelle
- cemiplimab
Andre undersøgelses-id-numre
- R15505-ONC-24144
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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
Studerer et amerikansk FDA-reguleret enhedsprodukt
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