Recruiting
Phase 1
Phase 2

REGN15505, Cemiplimab, REGN4336

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07594106

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Clear Cell Renal Cell Carcinoma (ccRCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN15505

REGN15505+Cemiplimab

REGN15505+REGN4336

Study Details

Brief summary:

This study is researching a new drug called REGN15505 when used alone or in combination with cemiplimab or in combination with REGN4336 in adult patients with mCRPC and ccRCC. The goal is to explore new ways to treat these cancers by helping immune cells target and destroy cancer cells.

The study will evaluate the use of REGN15505 when administered alone, in combination with cemiplimab, or in combination with REGN4336 for:

  • Any side effects of study drugs
  • How well the study drugs work
  • How much REGN15505, cemiplimab, and REGN4336 are in the blood at different times
  • If the body makes antibodies to REGN15505 or REGN4336, which may mean the study drugs will not work as well as expected
  • What is the best dose of REGN15505 when administered alone and with cemiplimab and the best dose of REGN15505 and REGN4336 when used in combination

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Clear Cell Renal Cell Carcinoma (ccRCC)

Study ID

NCT07594106

Start date

Jul 20, 2026

Status verified date

Sep, 2026

Completion date

Oct 27, 2030

Anticipated

Primary completion date

Oct 27, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Participants with mCRPC:

1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma
2. mCRPC with PSA value at screening ≥4 ng/mL and that has progressed within 6 months prior to screening as described in the protocol
3. Has received ≥2 lines of prior systemic therapy approved in the metastatic and/or castration-resistant setting as described in the protocol
4. Have had either Orchiectomy or be on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone <50 ng/dL AND agree to stay on LHRH agonist or antagonist therapy during the study

Participants with ccRCC:
5. Men and women with histologically or cytologically confirmed Renal Cell Carcinoma (RCC) with a clear-cell component
6. Diagnosis of metastatic ccRCC with at least 1 measurable lesion via Response evaluation criteria in solid tumors (RECIST) 1.1 criteria
7. Has progressed on or after ≥1 line of prior systemic therapy approved in the metastatic setting. Prior treatment must include an Anti Program Cell Death 1 (PD-1)/ Program Death Ligand 1 (PD-L1) therapy and either ipilimumab and/or a Tyrosine Kinase Inhibitor (TKI)

Key Exclusion Criteria:

For Both mCRPC and ccRCC Cohorts:

1. Has received treatment with an approved systemic therapy (including sipuleucel-T for mCRPC patients) 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 the protocol

mCRPC Cohort Only:
2. Has received prior Prostate Specific Membrane Antigen (PSMA)-targeting therapy with the exception of a PSMA-targeting radioligand (eg, 177Lu-PSMA-617)

Note: Other protocol defined inclusion/exclusion criteria apply

Study Design

Enrollment

265 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1: Monotherapy

REGN15505

experimental: Module 2: Combination 1

REGN15505 and Cemiplimab

experimental: Module 3: Combination 2

REGN15505 and REGN4336

Interventions

REGN15505

Administered per protocol

REGN15505+Cemiplimab

Administered per protocol

REGN15505+REGN4336

Administered per protocol

Primary outcome measure

  • Occurrence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 5 years ]
  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 5 years ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • Occurrence of Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 5 years ]
  • Composite Response (CompR) based on ≥50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic assessment of complete response (CR) or partial response (PR) [ Time Frame: Up to 5 years ]
  • Objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

City of Hope Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

City of Hope

Recruiting

Duarte, California, United States, 91010

H. Lee Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

City of Hope Chicago, City of Hope Cancer Center Chicago

Recruiting

Zion, Illinois, United States, 60099

Washington University

Recruiting

St Louis, Missouri, United States, 63110

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • Cemiplimab
  • PSMA
  • REGN4336
  • REGN15505
  • 4-1BB

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.