Investigator Initiated Trial of Syncrovax - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Williams Cancer Foundation
• Collaborator: Syncromune, Inc.

Criteria

Inclusion Criteria:

1. Male >18 years old

2. Provide written informed consent

3. Subjects with advanced and/or metastatic histologically or cytologically confirmed mCRPC who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available

4. Has an unobstructed urinary system before or after stenting

5. Able to undergo general anesthesia or conscious sedation

6. Eastern Cooperative Oncology Group (ECOG) performance status of < 2

7. Adequate organ and bone marrow function

8. All subjects with female partners of childbearing potential must use condoms for 5 months throughout treatment and following the last treatment

9. Has a prostate lesion accessible transperineally using transrectal ultrasound (TRUS) that is demonstrable on PET/CT scan and MRI and accessible for injection on TRUS or, if a radical prostatectomy has been performed, has a metastatic lesion or lymph node lesion that is demonstrable on an PET/CT scan and MRI and accessible by a percutaneous needle to permit immunotherapy infusion.

10. Participants receiving bone resorptive therapy (including, but not limited to, bis phosphonate or denosumab) must have been on stable doses for at least 6 weeks prior to enrollment

11. Adequate hematologic, renal, and hepatic function, defined as follows:

• Hematologic

• Absolute neutrophil count ≥ 1.5 x 109/L

• Lymphocyte count of ≥ 1.0 x 109/L

• Platelet count ≥ 100 x 109/L

• Hemoglobin ≥ 9.0 g/dL

• Renal function

• Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or creatinine clearance calculated by Cockcroft-Gault equation

• Hepatic function

• Alanine aminotransferase ≤ 3x upper limit of normal (ULN)

• Aspartate aminotransferase ≤ 3x ULN

• Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome

Exclusion Criteria:

1. Has bone metastasis as the only site of disease

2. Has a known additional malignancy that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma

3. Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to enrollment and has not recovered adequately from the toxicities and/or complications

4. Has an active infection (including tuberculosis) requiring systemic therapy

5. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

6. Has received a live vaccine within 30 days prior to consenting

7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first treatment

8. 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)

9. Visceral disease (liver or lung), brain metastases, malignant pleural effusions, or malignant ascites

10. Prior history of autoimmune disease except hypothyroidism

11. Any primary or acquired immunodeficiency

12. Active COVID infection or tests positive for COVID day before or day of planned treatment