A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer

Exclusion Criteria

• •Has a known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast.
• •Has an obstructed urinary system before or after stenting.
• •Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to the first dose of study treatment and has not recovered adequately from the toxicities and/or complications.
• •Has used any anticoagulants or other blood thinners pre-study treatments within the protocol-defined timelines.
• •Has an active infection (including tuberculosis) requiring systemic therapy.
• •Has a history of non-infectious pneumonitis that requires steroids.
• •Has received a live vaccine within 30 days prior to the enrollment.
• •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first study treatment.
• •Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g., New York Heart Association Class 4), or history of previous heart failure.
• •Fridericia corrected QT interval (QTcF) greater than (\>) 470 millisecond (msec) (men) on a 12-lead electrocardiogram (ECG) during the screening period.
• •Malignant pleural effusions or ascites that require immediate intervention.
• •Brain metastases (includes history of).
• •Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanaged diabetes (glycated haemoglobin \[HbA1c\] \>=6.5), cardiac arrhythmia (unstable or untreated), hypersensitivity, or other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the participant a poor candidate.
• •History of bone marrow/stem cell transplant.
• •Active coronavirus disease-2019 (COVID-19) infection or tests positive for COVID-19 a day before or the day of planned study treatment.
• •Participants who have active viral (any etiology) hepatitis are excluded.
• •Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen \[HBsAg\] test and a positive hepatitis B core antibody (anti-HBc) test) who have a viral load below the limit quantification (HBV deoxyribonucleic acid \[DNA\] titer \<1000 copies per milliliters \[cps/mL\] or 200 international units per milliliter \[IU/mL\]) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor.
• •Participants with complications or contraindications related to the liver, including intrahepatic biliary ductal dilation, uncorrectable bleeding diathesis, and decompensated liver failure, tumor burden of over 5 lesions, tumors greater than 5 cm in size, tumors in close proximity to vital structures, such as portal vein, biliary tree, or gastrointestinal tract.
• •Breast cancer gene (BRCA) mutation testing will be required for participants not previously treated with a PARP inhibitor, unless BRCA status is established prior to screening. If PARP-positive and participants agree to PARP therapy, they will be ineligible.
• •Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study treatment, or interfere with participants compliance or conduct of this study.
• •Known visceral metastases.
• •Known substance abuse or medical, psychological, or social conditions that may interfere with patient's participation.