Study on the Safety and Effectiveness of REGN4336 Alone and with Other Drugs for Advanced Prostate Cancer

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05125016

Provider View

This clinical trial is testing a new drug, REGN4336, to see if it is safe and effective for treating advanced prostate cancer. Some participants will also receive other investigational drugs, such as cemiplimab or REGN5678, to see if these combinations work better.

Patient Parameters

Program Overview

The study is exploring a new cancer treatment called REGN4336, which is being tested alone and in combination with other drugs like cemiplimab and REGN5678. These drugs are a type of immunotherapy designed to help the body's immune system attack cancer cells. The study has two parts: the first part aims to find a safe dose of REGN4336, and the second part tests how well it works to shrink tumors. Researchers are also looking at potential side effects, how the drug is processed in the body, and whether the body develops antibodies against the drugs.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of prostate cancer that is not small cell type.
  • Have advanced prostate cancer that has spread and is resistant to standard hormone therapy, with a PSA level of 4 ng/mL or higher.
  • The cancer must have worsened in the last 6 months, shown by rising PSA levels, new growths in soft tissue or bones, or both.
  • Have tried at least two previous treatments for advanced prostate cancer, including one newer hormone therapy like abiraterone or enzalutamide.

Exclusion Criteria

  • Have received any cancer treatment within the last 3 weeks or have not recovered from side effects of previous treatments.
  • Have had certain immune therapies recently, except for Sipuleucel-T.
  • Have had previous treatments targeting PSMA, except for specific approved therapies.
  • Need ongoing steroid treatment at doses higher than 10 mg of prednisone per day.
  • Have a significant autoimmune disease that needed treatment in the last 5 years.
  • Have had brain infections, severe neurological diseases, or uncontrolled seizures in the past year.
  • Have uncontrolled HIV, hepatitis B or C, or other immune system deficiencies.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.