Study on the Safety and Effectiveness of REGN5678 Alone or with Cemiplimab for Adults with Advanced Prostate Cancer and Other Tumors

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03972657

Provider View

This clinical trial is testing a new drug, REGN5678, alone or combined with cemiplimab, to see if it is safe and effective in treating advanced prostate cancer and other tumors. The study will explore how the drugs work in the body and their impact on tumor size.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug REGN5678, used alone or with cemiplimab, is safe and can help treat advanced prostate cancer and other tumors. The study has two parts. In Part 1, researchers will determine a safe dose of REGN5678, either alone or with cemiplimab. In Part 2, they will use the dose found in Part 1 to see how well the treatment works in shrinking tumors. The study will also look at possible side effects, how the drugs work in the body, and how much of the drugs are present in the blood.

Eligibility Criteria

Inclusion Criteria

  • For prostate cancer participants:

    • Men with confirmed prostate cancer that is not small cell type.
    • PSA level of 4 ng/mL or higher that has worsened in the last 6 months.
    • Have had at least two previous treatments for advanced prostate cancer, including one second-generation anti-androgen therapy.
    • For certain participants, must have received at least two doses of a specific radiotherapy.

  • For kidney cancer participants:

    • Men and women with confirmed kidney cancer with a clear-cell component.
    • Have metastatic kidney cancer with at least one measurable tumor.
    • Have had at least one previous treatment for advanced kidney cancer, including specific immunotherapies or a tyrosine kinase inhibitor.

Exclusion Criteria

  • Have received any approved cancer treatment within 3 weeks before starting the study or have not recovered from side effects of previous treatments.
  • Have had any previous biological therapy within a certain time frame before starting the study.
  • Have had previous PSMA-targeting therapy, except for specific radiotherapy, in prostate cancer participants.
  • For dose escalation, have had previous cancer immunotherapy (except sipuleucel-T) within a certain time frame before starting the study.
  • For dose expansion in prostate cancer, have had previous cancer immunotherapy.
  • Require ongoing steroid treatment above a certain dose within 1 week before starting the study.
  • Have significant autoimmune disease requiring treatment in the last 5 years.
  • Have had brain inflammation, neurodegenerative disease, or uncontrolled seizures in the last year.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections, or a diagnosis of immunodeficiency.

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