A Phase 2 Study of a Presurgical CD40 Agonist (2141-V11) Plus Standard Treatments in People With Prostate Cancer

Share

Full Title

Phase II Study Evaluating the Effects of Single Site Intratumoral Injections of Anti-CD40 Agonist Antibody (2141-V11) Given as Monotherapy Prior to Radical Prostatectomy to Men with Intermediate Risk Disease and in Combination with Androgen Deprivation Therapy for Those with High Risk Localized and Low Volume Metastatic Disease

Purpose

Researchers are assessing a new treatment for people with prostate cancer that has not spread but has a high risk of spreading. The new treatment, 2141-V11, will be given with standard prostate cancer therapies.

2141-V11 works by binding to and turning on a protein called CD40, which is on cells of your immune system. This action helps activate the immune system to find and kill cancer cells. When given before surgery, combining 2141-V11 with standard treatments may work against prostate cancer better than standard treatments alone. It may also reduce the chance of the cancer coming back. 2141-V11 is injected directly into the tumor.

If you join this study, you will get 2141-V11 plus:

  • Androgen deprivation therapy drugs, which reduce the levels of hormones that fuel prostate cancer growth.
  • Drugs such as enzalutamide, apalutamide, and darolutamide, which block the effects of hormones.
  • Surgery after getting the prostate cancer medications. Surgeons will remove the prostate and some nearby lymph nodes that may have cancer cells.
  • Radiation therapy after surgery, if your study doctor thinks it is needed.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have newly diagnosed prostate cancer that has not yet been treated.
  • Have prostate cancer that is only in one location and has an intermediate or high risk of coming back.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Matthew Dallos’ office at 646-888-4234.

Protocol

23-252

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06347705