NCT03274479进行中（未招募）1 期
Phase I Trial of PBF-1129 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of PBF-1129
研究概览
简要总结
Phase I clinical trial in Eastern Cooperative Oncology Group (ECOG) 0-1 patients with locally advanced or metastatic NSCLC to evaluate safety and tolerability of the compound PBF-1129, an Adenosine A2b receptor antagonist. The phase I dose escalation will be conducted 3+3 method. Pharmacokinetic (PK) data will be also obtained.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC.
- •Life expectancy greater or equal to 3 months, as determined by the investigator -Patients must have progressed on the standard therapy, including platinum based - chemotherapy. Patients with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations must have progressed on standard treatment options including EGFR, ALK, or ROS-1-directed therapies.
- •No limits to the prior lines of treatment
- •ECOG performance status of 0/1
- •Measurable Disease by RECIST v1.1
- •Age greater than 18 years.
- •Adequate bone marrow, renal and hepatic function:
- •Absolute neutrophil count (ANC) ≥ 1500 /µL
- •White blood cell count (WBC) t ≥ 2.5 x 109/L (2500/µL)
- •Lymphocyte count ≥ 0.5 x 109/L (500/µL)
- •Platelet count ≥ 100 x 109/L (100,000/µL) without transfusion
- •Hemoglobin ≥ (9.0 g/dL) - patients may be transfused to meet this criterion.
- •Aspartate aminotransferase AST, alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN)
- •Serum bilirubin ≤ 1.5 x ULN, with the exception of patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN
- •Creatinine clearance >60 mL/min (calculated using the Cockcroft-Gault formula) or by 24-hours urine collection
- •Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- •Subject is willing and able to comply with the protocol for the duration of the study
排除标准
- •Participation in another clinical study with an investigational product during the last 4 weeks or 5 half-lives prior to starting on treatment.
- •Symptomatic and/or untreated or actively progressing central nervous system (CNS) metastases or leptomeningeal disease. Patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met:
- •The patient has not received stereotactic radiotherapy within 7 days prior to initiation of study treatment or whole-brain radiotherapy within 14 days prior to initiation of study treatment.
- •The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
- •Serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment.
- •Concurrent use of other anticancer approved or investigational agents is not allowed.
- •Autoimmune disorder
- •Prior malignancy in past 2 years or as identified in Section 7.2 of this protocol
- •Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- •Patients receiving systemic steroids ≥ 10mg/day of prednisone or the equivalent
- •Smoking (cigarettes, cigars or pipes) must be discontinued at least 7 days prior to initiating study drug administration; smoking cessation products (transdermal nicotine patches or chewing gum may be used.
- •Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female subjects must either be of non-reproductive potential or have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
研究组 & 干预措施
PBF-1129_40mg
Experimental
干预措施: PBF-1129 (Drug)
PBF-1129_80mg
Experimental
干预措施: PBF-1129 (Drug)
PBF-1129_160mg
Experimental
干预措施: PBF-1129 (Drug)
PBF-1129_320mg
Experimental
干预措施: PBF-1129 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of PBF-1129
时间窗: 28 days
The MTD evaluation will be based on the Dose-limiting Toxicity (DLT) of the treated Population, which includes all subjects who receive any dose of PBF-1129, and will include Adverse events (AEs), Serious Adverse events (SAEs), laboratory evaluations and electrocardiogram (ECG) results
次要结局
- Time to PBF-1129 peak concentration in plasma at steady state "Tmax,ss"(days 1 and 29)
- Time to PBF-1129 peak concentration in plasma "Tmax"(days 1 and 29)
- The area under PBF-1129 plasma concentration-time curve to infinite time "AUC(0-inf)"(days 1 and 29)
- PBF-1129 peak concentration in plasma "Cmax"(days 1 and 29)
- PBF-1129 peak concentration in plasma at steady state"Cmax,ss"(days 1 and 29)
- The area under PBF-1129 plasma concentration-time curve up to time 't' "AUC(0-t)"(days 1 and 29)
- The area under PBF-1129 plasma concentration-time curve over the dosing interval "AUC(0-τ)"(days 1 and 29)
- PBF-1129 half-life in plasma " t½"(days 1 and 29)
- Efficacy as measured by Objective response rate (ORR)(2 years)
- Efficacy as measured by Disease control rate (DCR)(2 years)
- Efficacy as measured by duration of response (DoR)(2 years)
- Efficacy as measured by progression-free survival (PFS)(2 years)
- Efficacy as measured by overall survival (OS)(2 years)
研究者
研究点 (1)
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