Investigator Initiated Trial of Syncrovax - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SV-102 Treatment Arm SV-102 Treatment Arm |
Drug: SV-102
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 immunopharmacologic effects.
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Outcome Measures
Primary Outcome Measures
- Anti-tumor activity [4-6 weeks after each treatment]
To assess the preliminary antitumor activity of SV-102 as measured by RECIST 1.1 and iRECIST
Secondary Outcome Measures
- To evaluate rate of adverse events (AEs), including serious adverse events (SAEs) and AEs leading to treatment discontinuation [Beginning at baseline and including pre-intervention/procedure and through study completion over 1 year period]
Safety assessment will include protocol-specified periodic physical examination findings, vital signs, ECOG performance status, protocol-specified laboratory variables (e.g. hematology, coagulation tests, serum chemistry, urine tests), AEs using CTCAE v5.1, and SAEs.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male >18 years old
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Provide written informed consent
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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
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Has an unobstructed urinary system before or after stenting
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Able to undergo general anesthesia or conscious sedation
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Eastern Cooperative Oncology Group (ECOG) performance status of < 2
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Adequate organ and bone marrow function
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All subjects with female partners of childbearing potential must use condoms for 5 months throughout treatment and following the last treatment
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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.
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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
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Adequate hematologic, renal, and hepatic function, defined as follows:
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Hematologic
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Absolute neutrophil count ≥ 1.5 x 109/L
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Lymphocyte count of ≥ 1.0 x 109/L
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Platelet count ≥ 100 x 109/L
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Hemoglobin ≥ 9.0 g/dL
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Renal function
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Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or creatinine clearance calculated by Cockcroft-Gault equation
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Hepatic function
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Alanine aminotransferase ≤ 3x upper limit of normal (ULN)
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Aspartate aminotransferase ≤ 3x ULN
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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:
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Has bone metastasis as the only site of disease
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Has a known additional malignancy that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma
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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
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Has an active infection (including tuberculosis) requiring systemic therapy
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Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
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Has received a live vaccine within 30 days prior to consenting
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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
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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
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Visceral disease (liver or lung), brain metastases, malignant pleural effusions, or malignant ascites
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Prior history of autoimmune disease except hypothyroidism
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Any primary or acquired immunodeficiency
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Active COVID infection or tests positive for COVID day before or day of planned treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Diomed | Mexico City | Mexico | 11810 |
Sponsors and Collaborators
- Williams Cancer Foundation
- Syncromune, Inc.
Investigators
- Principal Investigator: Jason Williams, MD, Williams Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIT SV-102