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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
City of Hope Phoenix
Goodyear, Arizona, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGH. Lee Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGCity of Hope Chicago, City of Hope Cancer Center Chicago
Zion, Illinois, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGOccurrence of Dose Limiting Toxicities (DLTs)
Dose Escalation
Time frame: Up to 5 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Dose Escalation
Time frame: Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
Dose Escalation
Time frame: Up to 5 years
Occurrence of Adverse Events of Special Interest (AESIs)
Dose Escalation
Time frame: 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)
Dose Expansion-mCRPC
Time frame: Up to 5 years
Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Dose Expansion-ccRCC
Time frame: Up to 5 years
Occurrence of TEAEs
Dose Expansion
Time frame: Up to 5 years
Occurrence of SAEs
Dose Expansion
Time frame: Up to 5 years
Occurrence of AESIs
Dose Expansion
Time frame: Up to 5 years
CompR based on ≥50% decline of PSA from baseline and/or confirmed radiographic assessment of CR or PR
Dose Escalation-mCRPC
Time frame: Up to 5 years
Percentage of participants with ≥50% reduction of PSA
Dose Escalation and Dose Expansion Phases - mCRPC cohorts
Time frame: Up to 5 years
Percentage of participants with ≥90% reduction in PSA
Dose Escalation and Dose Expansion - mCRPC cohorts
Time frame: Up to 5 years
Concentration of REGN15505 in serum
Dose Escalation and Expansion
Time frame: Up to 5 years
Occurrence of Anti Drug Antibodies (ADA) against REGN15505
Dose Escalation and Expansion
Time frame: Up to 5 years
Occurrence of ADA against REGN4336
Dose Escalation and Expansion
Time frame: Up to 5 years
Magnitude of ADA against REGN15505
Dose Escalation and Expansion
Time frame: Up to 5 years
Magnitude of ADA against REGN4336
Dose Escalation and Expansion
Time frame: Up to 5 years
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