Study on REGN15505 Alone or with Cemiplimab or REGN4336 for Treating Advanced Prostate and Kidney Cancer

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60

ClinicalTrials ID:NCT07594106

This clinical trial is testing a new drug, REGN15505, alone or combined with other drugs, to treat advanced prostate and kidney cancers. The study aims to find out how well these treatments work, their side effects, and the best doses.

Patient Parameters

Parameter	Options

Program Overview

This study is exploring a new treatment called REGN15505 for advanced prostate cancer (mCRPC) and kidney cancer (ccRCC). Researchers are testing REGN15505 by itself, with another drug called cemiplimab, or with REGN4336. The study will look at how well these treatments work, any side effects, and how the body processes the drugs. It will also check if the body makes antibodies that might affect how well the drugs work.

Eligibility Criteria

Inclusion Criteria

For prostate cancer (mCRPC):
- Men with confirmed prostate cancer that is not small cell type.
- Cancer has spread and is resistant to hormone therapy, with a PSA level of 4 ng/mL or higher.
- Cancer has worsened within the last 6 months.
- Have had at least two previous treatments for advanced cancer.
- Have had surgery to remove the testicles or are on hormone therapy to lower testosterone levels and agree to continue this during the study.
For kidney cancer (ccRCC):
- Men and women with confirmed kidney cancer that includes clear-cell type.
- Cancer has spread and has at least one measurable tumor.
- Cancer has worsened after at least one previous treatment, which included PD-1/PD-L1 therapy and either ipilimumab or a Tyrosine Kinase Inhibitor.

Exclusion Criteria

For both prostate and kidney cancer groups:
- Have received any approved cancer treatment within 3 weeks before starting the study or have not recovered from side effects of previous treatments.
For prostate cancer group only:
- Have received previous PSMA-targeting therapy, except for certain radioligand treatments.

Note: Other specific criteria may apply as defined in the study protocol.

Locations

FACILITY	ZIP	CITY	STATE
City of Hope Phoenix	85338	Goodyear	Arizona
City of Hope	91010	Duarte	California
City of Hope Chicago, City of Hope Cancer Center Chicago	60099	Zion	Illinois
The University of Texas MD Anderson Cancer Center	77030	Houston	Texas

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