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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05125016
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN4336 — DRUG
    Administered per the protocol
  • REGN5678 — DRUG
    Administered per the protocol

Study Details

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)

Key Dates

Start date
Nov 30, 2021
Status verified
Apr 2026
Primary completion
Mar 28, 2030
Completion
Mar 28, 2030

Study Design

Enrollment
228 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1- Monotherapy
  • Experimental: Module 3-Combo Therapy

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: up to 21 days ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Stanford University Medical Center - Blake Wilbur DrivePalo AltoCalifornia94304-
Yale University HospitalNew HavenConnecticut06510-
Norton Cancer InstituteLouisvilleKentucky40207-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Roswell Park Cancer InstituteBuffaloNew York14263-
Atrium Health Levine Cancer InstituteCharlotteNorth Carolina28204-
The Ohio State University James Cancer HospitalColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Penn Medicine University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
MD Anderson Cancer CenterHoustonTexas77030-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Palo Alto, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Stanford University Medical Center - Blake Wilbur Drive· Palo Alto, CAYale University Hospital· New Haven, CTNorton Cancer Institute· Louisville, KYUniversity of Maryland Greenebaum Cancer Center· Baltimore, MDRutgers Cancer Institute of New Jersey· New Brunswick, NJRoswell Park Cancer Institute· Buffalo, NY

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