A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens
研究概览
简要总结
This is a single-institution, single arm, open label, window of opportunity clinical trial that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects of the novel study drugs in subjects with resectable solid tumor malignancies.
Each Sub-protocol conducted under the Master Protocol will evaluate different novel therapeutic agent(s).
Estimated enrollment is 15 subjects per Sub-Protocol.
详细描述
Patients will have a short-course (4-weeks) administration of a given compound in the timeframe between the diagnostic biopsy and the surgical resection. A pre-treatment tumor biopsy will be obtained, and blood samples will be collected before, during, and at the end of 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have biopsy-proven solid tumor that is eligible for elective surgical resection, disease does not require immediate therapy, and there is NO approved/ standard therapy available that is shown to prolong overall survival.
- •ECOG performance status of 0 or
- •Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy.
- •Willing to provide tissue and blood samples for research.
排除标准
- •The following solid tumors are NOT eligible: Primary brain tumor, Ocular melanoma, Head and neck cancer, Breast cancer, Prostate cancer, Testicular cancer, and Stage III rectal cancer.
- •Any active malignancy within 3 years prior, except: Adequately treated basal cell or squamous cell skin cancer, or early stage cancers (carcinoma in situ or stage 1) treated with curative intent.
- •Any uncontrolled intercurrent illness, including but not limited to: Symptomatic congestive heart failure, Unstable angina pectoris or coronary angioplasty or stenting within 6 months prior to enrollment, Cardiac arrhythmia, Psychiatric illness or social situations that would limit compliance with study requirements, or Ongoing or active infection.
- •Any known sensitivity to or history of allergic reaction to compounds of similar chemical or biological composition of study drug(s).
- •Unwilling or unable to follow the study schedule.
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Sub-Protocol A
Epacadostat
干预措施: Epacadostat (Drug)
结局指标
主要结局
Pharmacodynamic effects as measured by changes in biomarkers in pre- and post-dose tumor and blood specimens
时间窗: Approximately 1 year
To establish baseline levels and measure pharmacodynamic biomarker changes in tumor and/or blood samples after treatment with the study drug. Sub- Protocol A will focus on changes in CD8+ T cells, CD4+Foxp3+ cells, NK cells, DCs and immune checkpoints.
次要结局
- Safety and tolerability as measured by incidence of AEs (Adverse Events)(Approximately 1 year)
- Pathological Response Rate as measured by correlation of biomarkers in tumor and/or blood specimens(Approximately 1 year)
- Overall Survival(Approximately 2 years)