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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
Sponsor: Regeneron Pharmaceuticals
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
265
Start Date
2026-07-20
Completion Date
2030-10-27
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
REGN15505
Administered per protocol
REGN15505+Cemiplimab
Administered per protocol
REGN15505+REGN4336
Administered per protocol
Locations (4)
City of Hope Phoenix
Goodyear, Arizona, United States
City of Hope
Duarte, California, United States
City of Hope Chicago, City of Hope Cancer Center Chicago
Zion, Illinois, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States