This trial is a phase II, randomized, open label study designed to evaluate safety, tolerability and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity, and of VACXS15-PC01, a prostate cancer (PC)-specific multi-peptide vaccine, both administered as single agent or in combination to patients affected with biochemical recurrence (BCR) of PC after local therapy with curative intent. Patients will not receive other treatments during trial participation.
Understand and voluntarily sign an IC document prior to any study related assessments/procedures
Understand and voluntarily sign an IC document prior to any study related assessments/procedures
Patient is able to understand and comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
Men aged ≥ 18 and ≤80 years
• PSA >5 ng/mL (at screening)
Patients who are receiving or have previously received androgen deprivation treatment.
Patients who are planned to or are undergoing salvage therapy (e.g. radiation)
Clinically significant xerostomia (dry mouth >1grade according to CTCAE v6.0)
Parallel
PSMAxCD3, bispecific antibody CC-1
DrugCC-1 is applied subcutaneously once per week for 12 weeks in Arm 2. Due to priming doses up to 14 applications are planned.
Multipeptide Vaccine VAC-XS15-PC01
DrugThe vaccine VAC-XS15-PC01 consists of 300 µg of each of 10 PC-associated peptides. The vaccine cocktail (final volume 500 µL) will be administered subcutaneously (SC), adjuvanted with the TLR1/2 ligand XS15 (50 µg) and emulsified in Montanide ISA 51 VG at a 1:1 ratio. A total of three vaccinations are planned in Arm 1, administered 4 weeks apart from each other.
PSA response defined as ≥50% reduction in PSA at FU1 compared to baseline.
PSA serum levels \[ng/ml\] are determined during screening, before every treatment, and then every 30 days until end of follow up. PSA serum levels for one study patient should be locally assessed in the same lab during the whole study treatment. Furthermore, 5ml serum are taken and should be processed locally and stored at -80 °C at the study site. Tübingen for central assessment of PSA.
Click on the lead sponsor to view all of their trials.
