TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy

NCT04701021 | Completed Phase 1 DMC

• 1 other identifier: TENDU-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate; vaccine; cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of safety and tolerability of TENDU vaccine

  Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.

  Time from enrollment until 6 months after last dose

Secondary Outcomes (3)

• Assessment of Immunological response

  Time from enrollment until 6 months after last dose

• Assessment of anti-tetanus protein and anti-MTTE titers

  Time from enrollment until 6 months after last dose

• Assessment of Anti-tumor activity

  Time from enrollment until 6 months after last dose

Other Outcomes (2)

• Assessment of antibody titers

  Time from enrollment until 6 months after last dose

• Assessment of possible biomarkers

  Time from enrollment until 6 months after last dose

Study Arms (1)

TENDU

EXPERIMENTAL

Three different doses of the TENDU vaccine are to be investigated: 40, 400 and 960μg.

Biological: TENDU

Interventions

TENDU BIOLOGICAL

The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.

TENDU

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males ≥18 years of age
• PSA rise \>0.2 ng/mL less than 18 months following radical prostatectomy (RP) and pathological ISUP Grade 4-5 (Gleason score \>7), or persisting PSA \>0.1 ng/mL six weeks after RP and short PSA-DT, eligible for salvage radiotherapy and short term androgen deprivation therapy
• ECOG performance status 0 or 1
• Adequate organ function as indicated by the following laboratory values:
• White blood cell count ≥ 2,500/μL
• Absolute neutrophil count ≥ 1,000/μL
• Platelets ≥ 100,000/μL
• Haemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
• Serum total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN
• AST and ALT ≤ 2.5 x ULN
• Patients with potential to father children must use an acceptable contraceptive method
• Written informed consent prior to any study-specific evaluations

You may not qualify if:

• History of hematologic or primary solid tumor malignancy other than prostate cancer with remission less than 3 years prior study enrolment.
• Metastatic disease assessed by PSMA PET/CT
• Hypersensitivity to the active substance or any of its excipients
• Current use of androgen deprivation therapy or radiotherapy to the pelvis
• Known history or any evidence of active, non-infectious pneumonitis
• History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting study treatment
• Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule.
• Active infection requiring systemic therapy
• Diagnosis of immunodeficiency
• Any use of immunosuppressive (cytotoxic chemotherapy, systemic steroids) or immunomodulating agents within 8 weeks of study entry.
• Hepatitis B or Hepatitis C or Human Immunodeficiency Virus positive
• Expected to require any other form of systemic or localized antineoplastic therapy during the study
• Received any other investigational therapy within 4 weeks of the first dose of study treatment
• Any medical, psychological, social or neurological condition that would make it difficult for the patient to participate in the study and comply with the study procedures, restrictions, and requirements

Sponsors & Collaborators

• Ultimovacs ASA: lead

Study Sites (1)

Oslo University Hospital, The Norwegian Radium Hospital

Oslo, 0379, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Wolfgang Lilleby, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 8, 2021
• Study Start: February 17, 2021
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

NO (1)