Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: PAN-301-1
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 21 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed
      nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed
      prostate cancer, using a fixed dose escalation schema every 21 days.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed and dated written Ethics Committee approved informed consent

          2. Men aged 21 to 85 years with a histologic diagnosis of prostate cancer with a
             biochemical relapse following definitive local therapy (RP or radiation therapy)

          3. Patients are not eligible or are unwilling to receive additional definitive therapy
             following relapse (either RP or radiation therapy)

          4. No prior cytotoxic chemotherapy for the current cancer

          5. Normal electrocardiogram (ECG) or ECG with no clinically significant findings as
             determined by the Principal Investigator

          6. Presence of biochemically relapsed prostate cancer defined as either: 1) PSA > 2 ng/mL
             1 year following initial definitive treatment for prostate cancer: or, 2) PSA doubling
             time (greater than 0.2 ng/mL) < 12 months; or, 3) PSA velocity > 2 ng/mL/year at any
             time following radical prostatectomy or radiation therapy.

          7. Positive expression of HAAH in either archived tumor tissue (if available) or fresh
             serum

          8. No clinical or radiologic evidence of distant metastatic disease as measured by pelvic
             MRI or CT scan in addition to bone scan. These studies will need to be performed
             within 56 (+ 7 days) days prior to the start of the study.

          9. No history of immunosuppressive disease

         10. No evidence of active autoimmune disease. Active autoimmune disease is defined as any
             disease process that has specifically needed administration of immune suppressive and
             or cytoreductive therapy currently or within the last 1 year.

         11. Able and willing to comply with all study procedures

        Exclusion criteria:

          1. PSA doubling time of < 3 months

          2. Participation in a clinical trial within 30 days prior to enrollment

          3. Prior major surgery or radiation therapy within 4 weeks of enrollment

          4. Any illness or condition that in the opinion of the Investigator may affect the safety
             of the patient or the evaluation of any study endpoint

          5. Screening blood counts of the following:

             Hematopoietic:

             Absolute neutrophil count < 1500/μL, Platelets < 100,000/μL, Hemoglobin < 9 g/dL;

             Liver/Metabolic:

             Alanine aminotransferase (ALT) and aspartate transaminase (AST) > 2.5 × ULN range,
             Total bilirubin > 2 × ULN, Albumin < 2.8 g/dL;

             Renal:

             Creatinine clearance < 50 mL/min as predicted by the Cockcroft-Gault formula

          6. Subjects whose partners are WOCBP must use an adequate method of birth control while
             on study drug and at least for 3 weeks after discontinuation of study drug

          7. Current or anticipated concomitant immunosuppressive therapy (excluding nonsystemic
             inhaled, topical skin and/or eye drop-containing corticosteroids)

          8. Any concurrent condition requiring the continued use of systemic steroids (see above)
             or the use of immunosuppressive agents including methotrexate. All other systemic
             corticosteroids must be discontinued at least 4 weeks prior to first study treatment

          9. Receipt of any blood product within 1 month of enrollment

         10. Receipt of any vaccine within 4 weeks of enrollment

         11. Active drug or alcohol use or dependence that, in the opinion of the Investigator,
             would interfere with adherence to study requirements

         12. Been imprisoned or compulsorily detained (involuntarily incarcerated) for treatment of
             either a psychiatric or physical (i.e. infectious disease) illness

         13. Patients who have a history of coagulopathies, thrombosis or who are receiving active
             anticoagulation for any condition, such as but not limited to, artificial heart
             valves, atrial fibrillation, etc.

         14. Any other conditions judged by the Investigator that would limit the evaluation of a
             subject