Phase 2 Study of 2141-V11 Antibody Injections Before Surgery and With Hormone Therapy for Men with Intermediate to High Risk or Low Volume Metastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating whether combining the biological agent 2141-V11 with various standard treatments can be an effective approach for treating prostate cancer. This study focuses on men with clinically localized or locoregional high-risk disease, as well as those with low-volume metastatic disease where removing the primary tumor combined with other treatments might eliminate all cancer cells. The treatment works by activating the immune system to target and kill cancer cells, with researchers monitoring for complete cancer response and minimal residual disease MRD, which is a small number of cancer cells that may remain after treatment. Participants will receive intratumoral injections of the anti-CD40 agonist antibody 2141-V11. For men with intermediate risk disease, the antibody is given before radical prostatectomy, while those with high-risk localized or low-volume metastatic disease will receive the antibody in combination with androgen deprivation therapy. The study is non-randomized and involves single-site injections of 2141-V11 as monotherapy or combined with standard therapies, depending on the disease stage. During the study, participants will undergo clinical assessments including prostate MRI scans and staging evaluations. Researchers will monitor participants over 24 months to measure the number who achieve complete response or have minimal residual disease. Safety and treatment effects will be closely observed through laboratory tests, physical exams, and documentation of any side effects. Participants adherence to birth control requirements and other safety measures will also be monitored throughout the study period.

A Study of 2141-V11 in Combination With Standard Treatments in People With Prostate Cancer