Prostate CancerPhase 1NCT04701021
TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy
A Phase 1 study testing TENDU in people with Prostate Cancer, run by Ultimovacs ASA at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- TENDU
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 17 Feb 2021to 16 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, The Norwegian Radium Hospital
Oslo, 0379
About this study
Official title: Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients With Relapse After Primary Radical Prostatectomy
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.
Read the 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
- Being tested
- TENDU
- Keywords
- prostate, vaccine, cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENDUBiological
The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.
| Study group | Role | What they receive |
|---|---|---|
| TENDU | Experimental | Three different doses of the TENDU vaccine are to be investigated: 40, 400 and 960μg. Receives: Biological: TENDU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety and tolerability of TENDU vaccine
Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.
Measured: Time from enrollment until 6 months after last dose
Secondary outcomes (3)
Assessment of Immunological response
To evaluate the immunological response against the prostate specific peptides in the patients at baseline and after TENDU vaccinations.
Measured: Time from enrollment until 6 months after last dose
Assessment of anti-tetanus protein and anti-MTTE titers
To evaluate the preliminary anti-tumor activity of the TENDU vaccine in patients pre- and post the vaccination with Boostrix (including tetanus antigen) and the TENDU vaccinations by evaluation of anti-tetanus protein and anti-MTTE titers.
Measured: Time from enrollment until 6 months after last dose
Assessment of Anti-tumor activity
To evaluate the preliminary anti-tumor activity of the TENDU vaccine according to changes in the PSA, PAP, PSMA and PET/CT.
Measured: Time from enrollment until 6 months after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start17 Feb 2021
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ultimovacs ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Lilleby, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701021
- Sponsor's protocol ID
- TENDU-101
- Status last verified
- Jul 2024
- First submitted
- 5 Jan 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients With Relapse After Primary Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04701021
- Acronym / sponsor ID
- TENDU-101
- Conditions
- Prostate Cancer
- Keywords
- prostate, vaccine, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ultimovacs ASAIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENDU | Experimental | Biological: TENDUThree different doses of the TENDU vaccine are to be investigated: 40, 400 and 960μg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Patients with potential to father children must use an acceptable contraceptive method
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENDUThe vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively. | Biological | TENDU |
Primary outcome
Assessment of safety and tolerability of TENDU vaccine
Time frame: Time from enrollment until 6 months after last dose
Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.
3 secondary outcomes
Assessment of Immunological response
Time frame: Time from enrollment until 6 months after last dose
Assessment of anti-tetanus protein and anti-MTTE titers
Time frame: Time from enrollment until 6 months after last dose
Assessment of Anti-tumor activity
Time frame: Time from enrollment until 6 months after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Lilleby, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TENDU in people with Prostate Cancer, run by Ultimovacs ASA at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety and tolerability of TENDU vaccine (time frame: Time from enrollment until 6 months after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.