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Title Phase I, Open-label Trial to Evaluate the Safety and Immunogenicity of INO-5150 alone or in combination with INO-9012 in Men with Biochemically relapsed (PSA) Prostate Cancer

IRB INVO1815

CC 16-394

Hospital Main Campus

Phase Phase 1

Disease Prostate

Drug INO-5150 , INO-9012

Description

• Evaluate the safety and tolerability of INO-5150 alone or in combination with INO-9012 when delivered intramuscularly followed by electroporation in men with biochemically relapsed prostate cancer
• Evaluate the cellular and humoral immune responses to INO-5150 alone or in combination with INO-9012 when delivered intramuscularly followed by electroporation in men with biochemically relapsed prostate cancer

• Evaluate PSA kinetics to INO-5150 alone or in combination with INO-9012 when delivered intramuscularly followed by electroporation in men with biochemically relapsed prostate cancer

Inclusion Criteria

1. Signed and dated written Ethics Committee approved informed consent;
2. Men aged 18 to 80 years with a histologic diagnosis of prostate cancer;
3. Rising PSA defined as:
   • > 1.0 ng/ml and followed by a value higher than the first by any amount at minimum 1 week interval after definitive surgery (e.g. prostatectomy)[1] or
   • post-radiation nadir plus 2.0 ng/ml and followed by a value higher than the first by any amount at minimum 1 week interval after definitive local radiation therapy (e.g. external beam radiation or brachytherapy)
     • Subjects who have received salvage or adjuvant radiation therapy following definitive surgery (e.g. prostatectomy) are eligible if their postradiation PSA level reaches nadir plus 2.0 ng/ml;
4. Serum testosterone level:
   • Subjects with no history of androgen deprivation therapy:
     • A single measurement greater than 150 ng/dL or 5.2 nmol/L within 3 months of randomization;
   • Subjects with a history of androgen deprivation therapy (either in adjuvant or biochemical relapse setting):
     • The two most recent measurements of serum testosterone prior to randomization must fulfill the following criteria:
       • The two measurements are spaced at least 14 days apart;
       • Both must be measured within 3 months of randomization;
       • There must not be an increase of 50 ng/dL (or 1.7 nmol/L) or more between these two successive measurements;
5. Normal ECG or ECG with no clinically significant findings;
6. Screening laboratory (CBC, serum chemistry, liver panel, CPK, urinalysis) values within 1.5x ULN or 1.5x LLN performed up to 30 days prior to administration of Study Treatment;
7. No desire or plans to father future children and/or have a prior vasectomy;
8. Willing to use a condom and have their female sexual partners use another form of contraception such as an IUD, spermicidal foam/gel/film/cream/suppository, diaphragm with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant or a tubal ligation if the female partner could become pregnant. (This requirement should be followed from the time of the first Study Treatment until 28 days following the final Study Treatment);
9. Able and willing to comply with all study procedures

Exclusion Criteria

1. PSA doubling time (PSA-DT) of ≤ 3 months, using 2 PSA values at least 4 weeks apart, calculated according to the Memorial Sloan-Kettering Cancer Center nomogram (http://www.mskcc.org/mskcc/html/10088.cfm);
2. Clinical or radiologic evidence of distant metastatic disease other than small volume (<1.5 cm) nodes;
3. Participation in a clinical trial within 30 days of randomization;
4. Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
5. Prior major surgery or radiation therapy within 4 weeks of randomization;
6. Any prior chemotherapy;
7. History of HIV infection (e.g. positive serological test for HIV), immunosuppressive disease or clinically significant autoimmune disease;
8. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint;
9. Unprotected intercourse during the dosing phase (first dose until 28 days following last dose). Male subjects without a vasectomy must agree they may not be able to father future children and are required to use a condom and their female partners should use another form of contraception such as an IUD, spermicidal foam/gel/film/cream/suppository, diaphragm with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant or a tubal ligation if the female partner could become pregnant;
10. Current or anticipated concomitant immunosuppressive therapy (excluding nonsystemic inhaled, topical skin and/or eye drop-containing corticosteroids);
11. Any concurrent condition requiring the continued use of systemic steroids (see above) or the use of immunosuppressive agents (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;
12. Receipt of any blood product within 3 months of randomization;
13. Receipt of any vaccine within 4 weeks of randomization;
14. Presence of metal implants within 5 cm of the planned site(s) of injection
15. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
16. Imprisoned or compulsory detainment (involuntary incarceration) for treatment of either a psychiatric or physical (i.e. infectious disease) illness;
17. Any other conditions judged by the investigator that would limit the evaluation of a subject