NCT02009449已完成1 期
A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 17
- 主要终点
- Pharmacokinetic (PK) parameters
研究概览
简要总结
This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Part A Escalation Cohorts:
- •o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies
- •Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:
- •Tumors with all histological diagnosis or tissue origin may be enrolled
- •Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.
- •Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
- •At least 18 years of age
- •Performance Status of 0 or 1
- •Adequate organ function
排除标准
- •Hematologic malignancies
- •Pregnant or lactating
- •Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders
- •Myocardial infarction within the last 6 months
- •Unstable angina, or unstable cardiac arrhythmia requiring medication
- •Surgery within the last 28 days
- •Systemic fungal, bacterial, viral, or other infection
- •History of bleeding diathesis within the last 6 months
- •Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
结局指标
主要结局
Pharmacokinetic (PK) parameters
时间窗: up to 12 months
PK parameters including the serum trough concentration (Minimal Drug Concentration (Cmin)), the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).
Safety and tolerability as measured by incidence of adverse events
时间窗: up to 12 months
Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
时间窗: From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
时间窗: Day 29
Serum concentration of Pegilodecakin is reported.
次要结局
- Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC)(approximatley 4 months)
- Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)(up to 12 months)
- Anti-Pegilodecakin antibody formation(up to 12 months)
- Number of Participants With Anti-Pegilodecakin Antibody Formation(Up to 63 Months)
- Part A: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months))
- Part B: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months))
- Part C: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months))
- Part D: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months))
- Part E: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months))
- Part F: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months))
- Part G: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months))
- Part H: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months))
- Part I: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months))
- Part J: Number of Participants With Overall Response Rate (ORR)(From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months))
研究者
研究点 (17)
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