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
The purpose of this study is to see whether combining 2141-V11 with various standard treatments is an effective treatment approach for prostate cancer. 2141-V11 works by activating the immune system to find and kill cancer cells. Researchers will look at whether this treatment approach is able to completely get rid of cancer in participants, and they will check for the presence of minimal residual disease (MRD) in participants. MRD is a small number of cancer cells that can be detected in the body after treatment.
• Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
• Male aged 18 years and above
• Serum testosterone of ≥150 ng/dL (Cohorts B and C) except for patients currently on ADT.
• Adequate bone marrow, hepatic, and renal function, as evidenced within 28 days prior to treatment start by:
⁃ ANC ≥1500/µl (≥1000/µl if benign ethnic neutropenia) Hemoglobin ≥9 g/dL Platelet count ≥100,000/µl Creatinine Clearance Measure by Cockcroft-Gault Formula \>45 mL/min Total Bilirubin ≤ 1.8 mg/dl (Note: In participants with Gilbert's syndrome, if total bilirubin is 1.8 mg/dL, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible) SGOT (AST) ≤ 92.5 U/L SGPT (ALT) ≤ 137 U/L
• Participants must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the 8th edition American Joint Committee on Cancer (AJCC) staging system, recorded as the urologist's/medical oncologist's best clinical assessment of extent of local disease by digital rectal examination and/or available imaging studies such as transrectal ultrasound, CT scan, and/or MRI. (Applicable to Cohorts A, B and C).
• Candidate for RP with lymph node dissection as per the investigator
• Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
• Evidence of a prostate lesion on prostate magnetic resonance imaging scan