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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

NCT05125016 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2026-05-05

No results posted yet for this study

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)

Conditions

Interventions

DRUG

REGN4336

Administered per the protocol

DRUG

REGN5678

Administered per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2030-03-28
Completion
2030-03-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125016 on ClinicalTrials.gov