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A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer
NCT05125016 · View on ClinicalTrials.gov ↗
Study Summary
This study is researching an investigational drug called REGN4336. Some participants may receive additional investigational drugs in combination with REGN4336. These additional drugs include REGN5678, cemiplimab and sarilumab. The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug) and effectiveness of REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678. REGN4336, cemiplimab and REGN5678 are a type of treatment for cancer called immunotherapy,and are intended to activate T-cells to attack cancer cells. This study has 2 parts. The purpose of Part 1 is to determine a safe dose of REGN4336 when given alone or when given in combination with cemiplimab or REGN5678. The purpose of Part 2 is to use the REGN4336 dose(s) determined in Part 1 to further test how well REGN4336 works to shrink tumors either when given alone or in combination with cemiplimab or REGN5678. This study is looking at several other research questions, including: * What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678? * How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678? * Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG REGN5678
- DRUG Sarilumab
- DRUG REGN4336
Study Locations (14)
Pennsylvania
- Penn Medicine University of Pennsylvania Health System — Philadelphia
- Thomas Jefferson University Hospital — Philadelphia
- Fox Chase Cancer Center — Philadelphia
- Fox Chase Cancer Center — Philadelphia
California
- Stanford University Medical Center - Blake Wilbur Drive — Palo Alto
Connecticut
- Yale University Hospital — New Haven
Kentucky
- Norton Cancer Institute — Louisville
Maryland
- University of Maryland Greenebaum Cancer Center — Baltimore
New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick
New York
- Roswell Park Cancer Institute — Buffalo
North Carolina
- Atrium Health Levine Cancer Institute — Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 370 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2027-01-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05125016
The ClinicalTrials.gov registry entry for NCT05125016 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Castration-resistant Prostate Cancer appearing as the primary indexed condition, and to 4 interventions — of which Cemiplimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05125016 reports 14 study locations spanning 11 distinct geographic areas — top geographies include Pennsylvania, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05125016 about?
NCT05125016 is a clinical study titled "A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer". This study is researching an investigational drug called REGN4336. Some participants may receive additional investigational drugs in combination with REGN4336. These additional drugs include REGN5678, cemiplimab and sarilumab. The main purpose of this study is to determine the safety, tolerability ...
What is the current status of trial NCT05125016?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 370 participants. The study started on 2021-11-30. Estimated completion is 2027-01-14.
What conditions does trial NCT05125016 study?
This clinical trial studies the following conditions: Metastatic Castration-resistant Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05125016?
The interventions under investigation include: Cemiplimab (DRUG), REGN5678 (DRUG), Sarilumab (DRUG), REGN4336 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05125016?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05125016 being conducted?
This trial has 14 study locations across California, Connecticut, Kentucky, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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