Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Module 1: Monotherapy
REGN15505
  • Drug: REGN15505
    Administered per protocol
Experimental
Module 2: Combination 1
REGN15505 and Cemiplimab
  • Drug: REGN15505+Cemiplimab
    Administered per protocol
    Other names:
    • REGN2810
    • Libtayo
Experimental
Module 3: Combination 2
REGN15505 and REGN4336
  • Drug: REGN15505+REGN4336
    Administered per protocol

Recruiting Locations

City of Hope Phoenix
Goodyear, Arizona 85338

City of Hope
Duarte, California 91010

H. Lee Moffitt Cancer Center
Tampa, Florida 33612

City of Hope Chicago, City of Hope Cancer Center Chicago
Zion, Illinois 60099

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.