Ireland
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Recruiting Phase 2

Multi-peptide Vaccination and Bispecific PSMAxCD3 Antibody Treatment in Patients With Prostate Cancer

NCT07860047 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2026-09-24
Last updated
2026-10-06

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

PSMAxCD3, bispecific antibody CC-1Multipeptide Vaccine VAC-XS15-PC01

PSMAxCD3, bispecific antibody CC-1: CC-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: The 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.

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * Histologic diagnosis of prostatic adenocarcinoma * Biochemical recurrence (BCR): PSA recurrence after treatment with curative intent; PSA ≥0.2 ng/mL or PSA \> nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment; AND no distant metastasis upon PSMA-PET imaging * Patients are ineligible to receive available treatment alternatives * Low risk of rapid disease progression, defined as: o PSA-DT \> 1 year AND pathological ISUP grade \< 4 for men with prior RP OR Interval to BCR \> 18 months AND biopsy ISUP grade \< 4 for men with prior radiation therapy * In case of second relapse PSA-DT \> 9 months * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Exclusion Criteria: * • PSA \>5 ng/mL (at screening) * Patients who are receiving or have previously received androgen deprivation treatment. Except testosterone has recovered to normal levels: patients who have previously received anti-hormonal treatment testosterone must be \>12 nmol/l. * Patients who are planned to or are undergoing salvage therapy (e.g. radiation) * Clinically significant xerostomia (dry mouth \>1grade according to CTCAE v6.0) * Untreated current or prior distant metastasis of PC * Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and non-muscle invasive bladder cancer. * Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anti-cancer therapy * Clinical signs of active infection (\> grade 2 according to CTCAE v6.0) * History of HIV infection * Viral active or chronic hepatitis (HBV or HCV) * Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (\< 10 mg/ day), in the past 1 year * Ongoing relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) * Epilepsy requiring pharmacologic treatment * Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery. * Heart failure NYHA III/IV * Severe obstructive or restrictive ventilation disorder * Known intolerance to CC-1, or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in the respective drug products (CC-1, VAC-XS15-PC01) * Refrain from blood donation during the course of the study * Male patients have to refrain from sperm donations for 6 months after last IMP

Primary outcome measure(s)

  • PSA response defined as ≥50% reduction in PSA at FU1 compared to baseline. — Screening: 21 days before Cycle (C1);C1: Day (D) -1, D0 to D3, D8, D15, and D22; C2-3: D1, D8, D15, and D22 (each cycle is 22 days); End of Treatment (EOT): D29 of C3; Follow-Up 1-5: every 30 days after the EOT; End of study (EOS): 12 months after EOT
    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.

Trial sites (4)

FacilityCityRegionStatus
NCT Studienzentrale; Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg Heidelberg Baden-Wurttemberg Not Yet Recruiting
CCU Transltional Immunolgy, University Hospital Tübingen Tübingen Baden-Wurttemberg Recruiting
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin - Studienzentrale Onkologie Berlin Beriln Not Yet Recruiting
Universitätsklinikum Essen, Abteilung Urologie Essen North Rhine-Westphalia Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860047 on ClinicalTrials.gov ↗ ← All trials in Germany