Study on 2141-V11 Combined with Standard Treatments for Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06347705

This clinical trial is exploring whether adding a new drug, 2141-V11, to standard prostate cancer treatments can effectively eliminate cancer. The study will also check for any remaining cancer cells after treatment.

Patient Parameters

Program Overview

The aim of this study is to test if combining the new drug 2141-V11 with standard treatments can effectively treat prostate cancer. 2141-V11 helps the immune system find and destroy cancer cells. Researchers will see if this approach can completely remove cancer and check for any minimal residual disease (MRD), which means a small number of cancer cells left in the body after treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be willing to provide written consent and allow the use of health information for research.
  • Male, aged 18 years or older.
  • Have a testosterone level of at least 150 ng/dL (for certain groups), unless currently on hormone therapy.
  • Have good bone marrow, liver, and kidney function based on recent blood tests.
  • Have a clinical assessment of prostate cancer stage by a doctor within the last 90 days.
  • Be a candidate for prostate surgery with lymph node removal.
  • Agree to use condoms and another form of birth control if having sex with a woman who can become pregnant, and not donate sperm during the study and for 3 months after.
  • Have a detectable prostate lesion on an MRI scan.

Exclusion Criteria

  • Have had previous prostate surgery, radiation, or other treatments for prostate cancer.
  • Currently on hormone therapy started more than 8 weeks before the study.
  • Have had chemotherapy or experimental treatments for prostate cancer recently.
  • Have known cancer spread to the brain, liver, lungs, or other organs (except certain lymph nodes).
  • Have another active cancer or a history of cancer within the last 5 years, except for certain skin or early-stage cancers.
  • Have a significant medical condition that would make participation unsafe, such as:
    • Need for high-dose steroids.
    • Active infection needing treatment.
    • Uncontrolled high blood pressure.
    • Liver or kidney problems.
    • HIV with certain conditions.
    • Heart disease or recent heart attack.
    • History of seizures or conditions that may cause seizures.
    • Inflammatory bowel disease.
  • Taking medications that could interfere with the study treatment.
  • Known allergies to certain prostate cancer medications.
  • Unable to undergo an MRI scan.

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