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Recruiting Phase 2

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

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About this study

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.

Condition
Prostate Cancer
Tested
PSMAxCD3, bispecific antibody CC-1, Multipeptide Vaccine VAC-XS15-PC01
Sponsor
University Hospital Tuebingen

Who can join

Age
18 to 80 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer
  • 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 20

  • • 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

Where

4 sites, 4 recruiting

CCU Transltional Immunolgy, University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Recruiting

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin - Studienzentrale Onkologie

Berlin, Beriln, Germany

Recruiting

Universitätsklinikum Essen, Abteilung Urologie

Essen, North Rhine-Westphalia, Germany

Recruiting

NCT Studienzentrale; Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.