Treatment of Patients With Castration Resistant Prostate Cancer Using a Multi-Targeted Recombinant Ad5 PSA/MUC1/Brachyury Based Immunotherapy Vaccines
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Recommended Phase 2 Dose
研究概览
简要总结
Background:
Metastatic castration resistant prostate cancer (mCRPC) keeps growing even when the amount of testosterone in the body is reduced to very low levels. mCRPC is incurable. Researchers want to develop vaccines to teach the immune system to target and kill cancer cells. They want to test three of these vaccines (ETBX-071, ETBX-061, and ETBX-051) against mCRPC.
Objective:
To test the safety of combination ETBX-071, ETBX-061, and ETBX-051 and to study their effects on the immune system.
Eligibility:
People ages 18 and older with mCRPC that has not responded to standard therapies
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Computed tomography (CT) or magnetic resonance imaging (MRI) scans
Bone scan
Participants will get the vaccines as shots under the skin every 3 weeks for 3 doses. They may then have the shots every 8 weeks for up to 1 year.
Participants will keep a diary to record any symptoms from the vaccines.
Participants will have blood tests each time they get the vaccines. They will also have scans and other tests to measure the effect the vaccines have on their tumors.
Participants will have a visit within 28 days after their last treatment. This includes a physical exam and blood and urine tests.
Participants will then be contacted by phone every 3 months for the first year, every 6 months for the next 2 years, and every 12 months for another 2 years.
Participants will be asked to join a long-term follow up study.
详细描述
Background:
- The overall goal of the current project is to expand our immunotherapeutic approach for the treatment of prostate cancer employing a multi-targeted approach.
- Therapeutic cancer vaccines targeting overexpressed proteins offer a potential method to activate T cells against tumors.
- A novel adenovirus based vaccines targeting three (3) human tumor associated antigens (TAA), Prostate specific antigen (PSA), Mucin 1 (MUC1), and brachyury, respectively have demonstrated anti-tumor cytolytic T cell responses in pre-clinical animal models of cancer.
Objectives:
-To determine the overall safety and recommended phase 2 dose of a combination of three immunotherapeutic vaccines (ETBX-071, ETBX-061, and ETBX-051) when administered subcutaneously (SC) to subjects with metastatic castration resistant prostate cancer
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Recommended Phase 2 Dose
时间窗: Within the first 4 weeks after drug is administered.
RP2D is the maximum tolerated dose declared after ≤1 of 6 participants experience a dose-limiting toxicity within the first 4 weeks.
Number of Participants With Dose-Limiting Toxicities
时间窗: 4 weeks after receiving the first vaccine dose
A dose-limiting toxicity is defined as occurring within 28 days after the first vaccine administration and meeting on of these criteria: Any Grade 3 or greater toxicity or any Grade 2 or higher autoimmune reaction as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0; or generalized erythroderma or macular or papular rash.
次要结局
- Percentage of Participants With a Disease Control Rate (DCR) Lasting for at Least 6 Months(6 months post treatment)
- Percentage of Participants With an Objective Response(Objective response at any time point during treatment on study up to 1 year)
- Overall Survival (OS)(Every 3 weeks for the first 3 doses, then every 8 weeks up to 1 year then every 3 months for 12 months and then approximately every 6 months every 6 months for 24 months and then every 12 months thereafter for another 24 months.)
- Percentage of Overall Survival (OS) Probability at 12 Months and 24 Months(12 and 24 months after first treatment)
- Prostate-Specific Antigen Doubling Time (PSA DT) at Week 14 and End of Study(PSA DT was done once at week 14 and the second time at the end of study (any time point within a year while on study when they met criteria for progression))
- Progression-free Survival (PFS)(This was accessed every 3 weeks for the first 3 doses, then every 8 weeks up to 1 year (Arm 2).)
- Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)(Date treatment consent signed to date off study, approximately 8 months and 30 days for the Arm 1/Dose De-Escalation group, and 10 months and 25 days for the Arm 2/Dose Expansion group.)
- Duration of Response(Time from recorded partial response until development of progressive disease. This was accessed every 3 weeks for the first 3 doses and then every 8 weeks up to 1 year (Arm 2))
研究者
Marijo Bilusic, M.D.
Principal Investigator
National Cancer Institute (NCI)