NCT04701021

TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy

Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients With Relapse After Primary Radical Prostatectomy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ultimovacs ASA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	TENDU	The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.

Timeline

• Start date: 2021-02-17
• Primary completion: 2023-08-16
• Completion: 2023-08-16
• First posted: 2021-01-08
• Last updated: 2024-07-08

Locations

1 site across 1 country: Norway