Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer
Summary
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)
Arms & interventions
- DrugREGN4336
Administered per the protocol
- DrugREGN5678
Administered per the protocol
Outcome measures
Primary
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
Secondary
CRR of ≥50% decline of PSA and/or confirmed radiographic response of CR or PR
Time frame: Up to 5 years
Anti-Drug Antibodies (ADA) to REGN4336
Time frame: Up to 5 years
ADA to REGN4336 and REGN5678
Time frame: Up to 5 years
Incidence and severity of TEAEs
Time frame: Up to 5 years
Incidence and severity of SAEs
Time frame: Up to 5 years
Incidence and severity of AESIs
Time frame: Up to 5 years
REGN4336 concentrations in serum in combination with REGN5678
Time frame: Up to 5 years
Percentage of patients with ≥50% reduction in PSA confirmed by a second PSA test ≥3 weeks later
Time frame: Up to 5 years
Percentage of patients with ≥90% reduction in PSA confirmed by a second PSA test ≥3 weeks later
Time frame: UP to 5 years
Eligibility criteria
Study locations (14)
Stanford University Medical Center - Blake Wilbur Drive
Palo Alto, California, 94304
Yale University Hospital
New Haven, Connecticut, 06510
Norton Cancer Institute
Louisville, Kentucky, 40207
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Roswell Park Cancer Institute
Buffalo, New York, 14263
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
Penn Medicine University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
MD Anderson Cancer Center
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226