Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients With Relapse After Primary Radical Prostatectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Assessment of safety and tolerability of TENDU vaccine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assessment of safety and tolerability of TENDU vaccine
时间窗: Time from enrollment until 6 months after last dose
Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.
次要结局
- 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)