Recruiting
Phase 1
Phase 2

REGN4336 & Cemiplimab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT05125016

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN4336

REGN5678

Study Details

Brief 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

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT05125016

Start date

Nov 30, 2021

Status verified date

Apr, 2026

Completion date

Mar 28, 2030

Anticipated

Primary completion date

Mar 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
2. Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening, according to at least 1 of the following:

1. PSA progression as defined by a rising PSA level confirmed with an interval of ≥1 week between each assessment
2. Radiographic disease progression in soft tissue based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria with or without PSA progression
3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression NOTE: Measurable disease per RECIST version 1.1 per local reading at screening is not an eligibility criterion for enrollment
3. Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy \[ADT\]) including at least one second-generation anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)

Key Exclusion Criteria:

1. Has received treatment with an approved systemic biologic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities except for laboratory changes as described in inclusion criteria
2. Has received any previous systemic biologic or anti-cancer immunotherapy within 5 half-lives of first dose of study therapy, as described in the protocol
3. Has received prior Prostate-Specific Membrane Antigen (PSMA)-targeting therapy NOTE: Prior therapy with PSMA-targeting radioligand(s) (eg, 177Lu-PSMA-617) is permitted. However, a period of 12 weeks must elapse between the last dose of the PSMA- targeting radioligand and the first dose of study drug
4. Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
5. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
6. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \[ADLs\]) or uncontrolled seizures in the year prior to first dose of study therapy
7. Uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or diagnosis of immunodeficiency, as described in the protocol.

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study Design

Enrollment

228 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1- Monotherapy

experimental: Module 3-Combo Therapy

Interventions

REGN4336

Administered per the protocol

REGN5678

Administered per the protocol

Primary outcome measure

  • Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: up to 21 days ]
  • Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 5 years ]
  • Incidence and severity of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • Incidence and severity of Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 5 years ]
  • REGN4336 monotherapy concentrations in serum [ Time Frame: Up to 5 years ]
  • REGN4336 concentrations in serum in combination with REGN5678 [ Time Frame: Up to 5 years ]
  • Composite Response Rate (CRR) of ≥50% decline of prostate specific antigen (PSA) and/or confirmed radiographic response of complete response (CR) or partial response (PR) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Stanford University Medical Center - Blake Wilbur Drive

Recruiting

Palo Alto, California, United States, 94304

Yale University Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

University of Maryland Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

The Ohio State University James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

Penn Medicine University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • Treatment-experienced metastatic Castration-Resistant Prostate Cancer (mCRPC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-05-05.