EUCTR2015-004314-15-CZ进行中（未招募）1 期
A phase I/II, single-arm clinical trial to evaluate the safety and immune activation of the combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming adenovirus, in men with advanced metastatic castration-resistant prostate cancer.
SOTIO a.s.0 个研究点目标入组 15 人开始时间: 2016年6月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Males 18 years of age and older
- •2. Histologically or cytologically confirmed adenocarcinoma of the prostate
- •3. Radiographically documented metastatic disease (presence of skeletal or soft-tissue/visceral/nodal metastases) with evidence of disease according to the following criteria:
- •- Measurable lymph nodes (short axis = 15 mm) or visceral lesion measurable per RECIST v 1.1 or
- •- Two or more lesions on bone scan/imaging and with at least one soft tissue or visceral lesion being accessible for intratumoral administration of ONCOS-102 and biopsy.
- •4. ECOG performance status 0-1
- •5. PSA =2 ng/mL
- •6. Rising PSA levels after previous treatment failure.
- •7. Surgically or medically castrate with serum testosterone levels =1.7 nmol/L. Patients who have not had bilateral orchiectomy must be maintained on standard dosing of GnRH/LHRH analog therapy at appropriate frequency for the duration of the clinical trial.
- •8. Laboratory criteria:
- •a. White blood cell count (WBC) greater than 4,000/mm3 (4.0×109/L)
- •b. Platelet count of at least 100,000/mm3 (100×109/L)
- •c. Total bilirubin within normal limits (benign hereditary hyper-bilirubinemias, eg, Gilbert’s syndrome, are permitted)*
- •d. Serum alanine aminotransferase, aspartate aminotransferase, and creatinine <1.5×ULN *
- •*If the patient has liver metastases, these parameters might not be applicable and the decision on inclusion of the patient into the study is to be made by the Investigator after discussion with the Sponsor’s Medical Monitor.
- •9. Patients who have progressed following:
- •a. at least initial therapy (chemotherapy or treatment with a hormonal agent known to impact survival such as abiraterone and enzalutamide); or
- •b. one first-line chemotherapy regimen and one additional hormonal agent known to impact survival such as abiraterone and enzalutamide; or
- •c. failure of two lines of chemotherapy; or
- •d. failure of pre-chemotherapy abiraterone or enzalutamide and subsequent chemotherapy
- •10. Life expectancy of at least 12 months based on the Investigator’s judgement
- •11. Signed Informed Consent Form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1.Patients with neuroendocrine or small cell cancer of the prostate
- •2.History of other malignant disease (with the exception of the primary prostate cancer and non-melanoma skin tumors) in the past 5 years
- •3.Systemic immunosuppressive therapy apart from corticosteroids at a dose of less than 10 mg/day
- •4.Administration of experimental therapy within the last 4 weeks before start of screening
- •5.Treatment with immunotherapy within the last 3 months before start of screening
- •6.Treatment with radiopharmaceutical drugs within 8 weeks before start of screening
- •7.Patient significant co-morbidities (cardiovascular diseases, eg, unstable angina pectoris, uncontrolled hypertension, myocardial infarction, ventricular arrhythmia, or stroke within a 6-month period before the Baseline visit; congestive heart failure or cardiac arrhythmia not controlled by treatment; active severe infections; uncontrolled metabolic disorders; etc.)
- •8.Known hypersensitivity or allergic reaction (other than local inflammatory reaction or irritation at injection site) to DCVAC/PCa or its constituents, ie, CryoStor CS10 freeze medium (Biolife Solutions) containing 10% dimethyl sulfoxide
- •9.Uncontrolled co-morbidities including social conditions which in the Investigator’s opinion would prevent participation in/completion of the clinical trial
- •10.Patients known to be HIV positive or syphilitic
- •11.Known active (infectious) hepatitis B and active hepatitis C
- •12.Known central nervous malignancies such as glioma and brain metastases
- •13.Receipt of oncolytic virus treatment or vaccination with a live virus within 4 weeks of study start
- •14.History of organ transplantation
- •15.Any autoimmune diseases, therapies with monoclonal antibodies, any psychiatric disease, medical history of active TBC and any allogeneic stem cell transplantations in the last 5 years
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