NCT01978964已完成1 期
Maintenance Therapy With ONT-10, a Liposomal MUC1 Cancer Vaccine, in Patients Who Have Previously Received ONT-10
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events and lab abnormalities
研究概览
简要总结
This is an open label phase 1b maintenance therapy study to evaluate the long-term safety, immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients who have demonstrated safety and clinical benefit on the original ONT-10-001 phase 1 study.
详细描述
Open label Phase 1b maintenance therapy study to evaluate the long-term safety, immunogenicity, and anti-tumor effects of repeat-dose vaccination with ONT-10 in patients with previously treated Stage 3 or 4 solid tumors with histologies that have been associated with expression of the MUC1 antigen as described in the medical literature. Patients must have previously been enrolled on the Phase 1 clinical trial ONT-10-001, completed all treatment and follow-up through at least 12 weeks, experienced no dose limiting toxicity, and experienced no progression of disease per the immune-related Response Criteria. Patients will receive maintenance ONT-10 every 6 weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Was enrolled on the Phase 1 clinical trial ONT-10-001 and:
- •completed all treatment and follow-up through at least 12 weeks
- •experienced no dose limiting toxicity (DLT)
- •experienced no progression of disease per the irRC1
- •Patients enrolling in the retreatment cohort may have experienced localized disease progression that was treated with definitive therapy to return the patient to a state of stable disease. Examples include localized disease progression treated with complete surgical resection, a solitary brain metastasis treated with complete surgical resection or curative intent stereotactic radiosurgery, or a solitary bone metastasis that is treated with curative-dose radiation therapy.
- •Patients enrolling on the retreatment cohort must have locally and systemically stable disease following the definite local treatment.
- •Last received ONT-10 a maximum of 6 months (unless approved by the medical monitor) prior to receiving the first dose of maintenance or retreatment cohort therapy
- •ECOG 0 or 1
- •Adequate baseline hematological parameters as defined by white blood cell count (WBC) ≥ 3.5 x 103/µL, lymphocyte count ≥ 1.0 x 103/µL, platelet count ≥ 100 x 103/µL, and hemoglobin ≥ 9 g/dL
- •Adequate hepatic parameters as defined by total bilirubin ≤ 1.5 x upper limit of normal (ULN) and aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN
- •Serum creatinine ≤ 1.5 x ULN
- •Resolution of all prior ONT-10 related toxicities to ≤ Grade 1in severity
- •If female of child bearing potential, have a negative pregnancy test at screening
- •If fertile male or female of child-bearing potential, agree to consistently use a highly effective method of birth control (including birth control pills, barrier device, or intrauterine device) from the time of consent through 3 months following the last dose of study drug
- •Be able and willing to sign informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC)
排除标准
- •Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- •Received treatment with any systemic chemotherapy, experimental agent, or radiation therapy (with the exception of palliative localized radiation therapy) following completion of treatment on the ONT-10-001 study
- •Known history of autoimmune disease, arteritis, or vasculitis, including, but not limited to: lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), Grave's disease, Hashimoto's thyroiditis, Wegener's granulomatosis, temporal arteritis, and polyarteritis nodosa
- •Has untreated or uncontrolled central nervous system (CNS) metastases, including patients who require glucocorticoid therapy for CNS metastases
- •Known immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia; and/or other hereditary or congenital immunodeficiencies
- •Chronic steroid or immunosuppressive therapy (except for low dose corticosteroids for chronic obstructive pulmonary disease [COPD] or topical steroids, which are allowed)
- •Known to be positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •Administration of any vaccine ≤ 4 weeks prior to first maintenance or retreatment cohort dose of ONT-10 with the exception of influenza, pneumococcus, and Tdap
结局指标
主要结局
Incidence and severity of adverse events and lab abnormalities
时间窗: 20-60 weeks
次要结局
- Immunogenicity and anti-tumor activity(20-60 weeks)
研究者
研究点 (2)
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