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NCT05125016 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Regeneron Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
370
Enrollment target
14
Study locations

NCT05125016: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by Regeneron Pharmaceuticals.

NCT05125016 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 370 participants, above the 193-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (92% higher). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05125016, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
370 participants
Enrollment target
14
Study locations

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)?

Primary Outcome

Dose escalation

Conditions Studied

Metastatic Castration-Resistant Prostate Cancer

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

FieldValue
Enrollment Target 370 participants
Start Date 2021-11-30
Est. Completion 2027-01-14
Phase Phase 1
Regeneron Pharmaceuticals

280 total trials

What NCT05125016 shows while recruiting

NCT05125016 is an interventional study that assigns participants to a tested intervention. The registered 370 participants enrollment target is mid-sized for trials with a published cap, above the 193-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (92% higher).

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.

NCT05125016 lists 14 locations in 11 states (Pennsylvania, California, Connecticut).

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.

What interventions are being tested in trial NCT05125016?

The interventions under investigation include: Cemiplimab (DRUG), REGN5678 (DRUG), Sarilumab (DRUG), REGN4336 (DRUG).

Who is sponsoring clinical trial NCT05125016?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Metastatic Castration-Resistant Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05125016's enrollment target sits among peer trials

370 11th of 69 higher than 59 of 69 other Metastatic Castration-Resistant Prostate Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05125016

Source: ClinicalTrials.gov NCT05125016, the US trial registry maintained by the National Library of Medicine. NCT05125016 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.