This study is researching an investigational drug called REGN4336 both alone or together with another investigational drug called REGN5678. The study is focused on participants with previously treated metastatic prostate cancer. The main purpose of the study is to look at the safety, tolerability (how the body reacts to the drug) and effectiveness (how well the drug works to shrink tumors) of REGN4336 when given in combination with REGN5678. The study has 2 parts. The purpose of Part 1 is to determine a safe dose(s) of REGN4336 to be given alone or in combination with REGN5678. Part 1 is known as the "dose escalation" phase. The purpose of Part 2, (known as the "dose expansion" phase), is to use the doses of REGN4336 and REGN5678 selected in Part 1 to further test how well the combination treatment with REGN4336 and REGN5678 works to shrink tumors. The study is looking at several other research questions, including: * What side effects may happen from taking REGN4336 alone or in combination with REGN5678 * How well does REGN4336 in combination with REGN5678 reduce tumor size * How much REGN4336 is in the blood at different times when it is given alone or in combination with REGN5678 * Does the body make antibodies against the study drugs (REGN4336 or REGN5678)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
Stanford University Medical Center - Blake Wilbur Drive
Palo Alto, California, United States
RECRUITINGYale University Hospital
New Haven, Connecticut, United States
RECRUITINGNorton Cancer Institute
Louisville, Kentucky, United States
RECRUITINGUniversity of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
RECRUITINGRutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
RECRUITINGRoswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGAtrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
RECRUITINGThe Ohio State University James Cancer Hospital
Columbus, Ohio, United States
RECRUITINGPenn Medicine University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
RECRUITINGThomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITING...and 4 more locations
Incidence of Dose-Limiting Toxicities (DLTs)
Dose escalation
Time frame: up to 21 days
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Dose escalation
Time frame: Up to 5 years
Incidence and severity of Serious Adverse Events (SAEs)
Dose escalation
Time frame: Up to 5 years
Incidence and severity of Adverse Events of Special Interest (AESIs)
Dose escalation
Time frame: Up to 5 years
REGN4336 monotherapy concentrations in serum
Dose escalation
Time frame: Up to 5 years
REGN4336 concentrations in serum in combination with REGN5678
Dose escalation
Time frame: Up to 5 years
Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR)
Dose expansion
Time frame: Up to 5 years
CRR of ≥50% decline of PSA and/or confirmed radiographic response of CR or PR
Dose escalation
Time frame: Up to 5 years
Anti-Drug Antibodies (ADA) to REGN4336
Dose escalation
Time frame: Up to 5 years
ADA to REGN4336 and REGN5678
Dose escalation and dose expansion
Time frame: Up to 5 years
Incidence and severity of TEAEs
Dose expansion
Time frame: Up to 5 years
Incidence and severity of SAEs
Dose expansion
Time frame: Up to 5 years
Incidence and severity of AESIs
Dose expansion
Time frame: Up to 5 years
REGN4336 concentrations in serum in combination with REGN5678
Dose expansion
Time frame: Up to 5 years
Percentage of patients with ≥50% reduction in PSA confirmed by a second PSA test ≥3 weeks later
Dose escalation and dose expansion
Time frame: Up to 5 years
Percentage of patients with ≥90% reduction in PSA confirmed by a second PSA test ≥3 weeks later
Dose escalation and dose expansion
Time frame: UP to 5 years
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