This is a phase I, dose selection study of safety and effect of different doses of TENDU vaccine, a therapeutic peptide conjugate vaccine, in patients with relapse after primary radical prostatectomy.
This is a open label dose selection study to investigate the safety, tolerability, immune response and preliminary clinical effect of different doses of the TENDU vaccine. TENDU is a synthetic therapeutic peptide conjugate vaccine intended for treatment of prostate cancer. The patients enrolled in this study is adults with documented progressive disease after radical prostatectomy and who are eligible for salvage radiotherapy and short-term (6 months) androgen deprivation therapy. All patients taking part at the study must be vaccinated with a Boostrix vaccine (including tetanus antigen) one week prior to the first TENDU vaccine treatment. Three different doses, 40, 400 and 960 μg of the TENDU vaccine are to be investigated. The vaccine is administrated by subcutaneous injections with one injection per drug substance (four separate injections) consecutively. The TENDU vaccine will be given four times during a treatment period lasting for 6 weeks and followed up for 6 months after the last treatment. In total between 12 to 18 patients will be enrolled with a 3+3 design in each dose cohort. The first patient will receive the lowest dose of the TENDU vaccine, and after the treatment is completed, a safety evaluation will be done to evaluate enrolment of the next patients in this cohort. If one patient develops a dose limiting toxicity at a specific dose, an additional three patients are to be enrolled into that same dose cohort, and on the recommended dose an addition of 3 patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.
Oslo University Hospital, The Norwegian Radium Hospital
Oslo, Norway
Assessment of safety and tolerability of TENDU vaccine
Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.
Time frame: Time from enrollment until 6 months after last dose
Assessment of Immunological response
To evaluate the immunological response against the prostate specific peptides in the patients at baseline and after TENDU vaccinations.
Time frame: Time from enrollment until 6 months after last dose
Assessment of anti-tetanus protein and anti-MTTE titers
To evaluate the preliminary anti-tumor activity of the TENDU vaccine in patients pre- and post the vaccination with Boostrix (including tetanus antigen) and the TENDU vaccinations by evaluation of anti-tetanus protein and anti-MTTE titers.
Time frame: Time from enrollment until 6 months after last dose
Assessment of Anti-tumor activity
To evaluate the preliminary anti-tumor activity of the TENDU vaccine according to changes in the PSA, PAP, PSMA and PET/CT.
Time frame: Time from enrollment until 6 months after last dose
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