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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07594106
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Clear Cell Renal Cell Carcinoma (ccRCC)
  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN15505 — DRUG
    Administered per protocol
  • REGN15505+Cemiplimab — DRUG
    Administered per protocol
  • REGN15505+REGN4336 — DRUG
    Administered per protocol

Study Details

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

Key Dates

First listed
May 18, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Oct 27, 2030
Completion
Oct 27, 2030

Study Design

Enrollment
265 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1: Monotherapy
    REGN15505
  • Experimental: Module 2: Combination 1
    REGN15505 and Cemiplimab
  • Experimental: Module 3: Combination 2
    REGN15505 and REGN4336

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope PhoenixGoodyearArizona85338-
City of HopeDuarteCalifornia91010-
City of Hope Chicago, City of Hope Cancer Center ChicagoZionIllinois60099-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Goodyear, AZ

By research site
City of Hope Phoenix· Goodyear, AZCity of Hope· Duarte, CACity of Hope Chicago, City of Hope Cancer Center Chicago· Zion, ILThe University of Texas MD Anderson Cancer Center· Houston, TX

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