REGN15505 Alone or With Cemiplimab or REGN4336 in Advanced Prostate Cancer and Kidney Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2 interventional study evaluating REGN15505 as a single agent and in combination with cemiplimab or REGN4336 in adults with metastatic castration-resistant prostate cancer (mCRPC) or metastatic clear cell renal cell carcinoma (ccRCC). The study will assess safety, how well the drugs work, blood levels over time, potential immune responses against the drugs, and identify appropriate dosing for each setting. Participants may receive REGN15505 alone, REGN15505 with cemiplimab, or REGN15505 with REGN4336. Locations include City of Hope Phoenix, City of Hope Duarte, and H. Lee Moffitt Cancer Center. Primary goals include determining recommended doses and exploring preliminary efficacy signals in both cancer types.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope Phoenix
  Goodyear, Arizona, United States Recruiting
• City of Hope
  Duarte, California, United States Recruiting
• H. Lee Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• City of Hope Chicago, City of Hope Cancer Center Chicago
  Zion, Illinois, United States Recruiting
• Washington University
  St Louis, Missouri, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.