A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer
Start Date
11/30/2021
Completion Date
3/28/2030
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)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
REGN4336
REGN5678
Conditions
Locations
Stanford University Medical Center - Blake Wilbur Drive
Palo Alto, California 94304
United States
Yale University Hospital
New Haven, Connecticut 06510
United States
Norton Cancer Institute
Louisville, Kentucky 40207
United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina 28204
United States
The Ohio State University James Cancer Hospital
Columbus, Ohio 43210
United States
Penn Medicine University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States