Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-05-05
228
Participants Needed
14
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
- Metastatic castration-resistant prostate cancer with PSA value at screening of 4 ng/mL or higher
- Disease progression within 6 months prior to screening by rising PSA or radiographic disease progression
- Progression after or intolerance to at least 2 prior systemic therapies approved for metastatic or castration-resistant prostate cancer, including at least one second-generation anti-androgen therapy
- Ability to comply with study procedures and provide informed consent
You will not qualify if you...
- Treatment with approved systemic biologic therapy within 3 weeks before dosing or unresolved acute toxicities
- Previous systemic biologic or anti-cancer immunotherapy within 5 half-lives before study dose
- Prior prostate-specific membrane antigen (PSMA)-targeting therapy, except radioligand therapy with at least 12 weeks since last dose
- Ongoing continuous corticosteroid therapy over 10 mg prednisone/day within 1 week before first dose
- Significant autoimmune disease requiring systemic immunosuppressive treatment within past 5 years
- History of encephalitis, meningitis, neurodegenerative disease (except mild dementia not affecting daily living), or uncontrolled seizures within 1 year before first dose
- Uncontrolled HIV, hepatitis B or C infection, or immunodeficiency as defined in the protocol
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Stanford University Medical Center - Blake Wilbur Drive
Palo Alto, California, United States, 94304
Actively Recruiting
2
Yale University Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
4
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
5
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
6
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
7
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
8
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
9
Penn Medicine University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
11
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Withdrawn
12
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
13
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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