NCT02055066已完成1 期
A Phase 1b Study of ARGX-111 in Patients With Advanced Cancer Over-expressing the c-Met Protein.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
This a first-in-human study of an antibody blocking the function of the oncogene c-met in patients with cancer.
详细描述
This Phase 1b trial will characterize the safety profile of ARGX 111 and will thus provide the first elements towards establishing an accurate risk-benefit assessment for ARGX 111 in cancer patients.
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
- •Written informed consent.
- •Age ≥ 18 years.
- •Performance status of 0 or
- •Histological diagnosis of malignancy.
- •Cancer relapsing after, or refractory to standard therapy.
- •Malignancy over-expressing the c Met protein.
- •Presence of circulating tumor cells (CTCs).
- •At least one tumor lesion > 2 cm on PET/CT.
- •Serum albumin > 35 g/L.
- •Absolute neutrophil count (ANC) > 1.0 x 109/L.
- •Hemoglobin > 90 g/L (0.9 g/dL).
- •Platelet count ≥ 75 x 109/L.
- •Coagulation parameters ≤ 1.5 x ULN.
- •Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
- •Creatine Phosphokinase (CPK) ≤ 2.5 x ULN.
- •Serum creatinine ≤ 1.5 x ULN.
- •Ability to comply with protocol-specified procedures/evaluations and scheduled visits.
排除标准
- •History or clinical evidence of neoplastic central nervous system (CNS) involvement.
- •Major surgery within 4 weeks of ARGX 111 first dose administration.
- •Systemic glucocorticoid administration at doses greater than physiological replacement (prednisone 20 mg equivalent) within 3 weeks of ARGX 111 first dose administration.
- •Cytotoxic chemotherapy within 3 weeks of ARGX 111 first dose administration.
- •Radiation therapy with curative intent within 3 weeks of ARGX 111 first dose administration.
- •Biological therapy (monoclonal antibodies) within 4 weeks of ARGX 111 first dose administration.
- •Biological therapy (other than monoclonal antibodies) within 5 half-lives of ARGX 111 first dose administration.
- •Unresolved Grade 3 or 4 toxicity from prior therapy, including experimental therapy.
- •History of recurrent Grade 3 or 4 toxicity from anti c Met therapy.
- •Uncontrolled diabetes, defined as fasting glycemia > 150 mg/dl).
- •Active, untreated viral, bacterial, or systemic fungal infection.
- •Any clinical finding, including psychiatric and behavioral problems, which, in the opinion of the Investigator, precludes the patient from safely participating in the study.
- •Childbearing potential (unless using an adequate measure of contraception).
- •Pregnancy or lactation.
- •History of severe (Grade 3 or 4) hypersensitivity to recombinant proteins.
研究组 & 干预措施
Arm 1
Experimental
ARGX-111 0.3 mg/kg
干预措施: ARGX-111 (Drug)
Arm 2
Experimental
ARGX-111 1.0 mg/kg
干预措施: ARGX-111 (Drug)
Arm 3
Experimental
ARGX-111 3.0 mg/kg
干预措施: ARGX-111 (Drug)
Arm 4
Experimental
ARGX-111 10 mg/kg
干预措施: ARGX-111 (Drug)
结局指标
主要结局
Dose-limiting toxicity
时间窗: 1 month
Number of patients with grade 3 or 4 toxicity
次要结局
- Pharmacokinetic profiles (Cmax , Ctrough, AUC, Vd , clearance, and half-life)(C1 D1 (pre, 0h, 2h, 6h, 12h, 24h), C1D8, C1D15; Cycle ≥2 o D1 pre-/post-dose)
- Biomarkers (Hepatocyte growth factor; ADCC)(Base-line and pre-dose at each cycle for an average of 4 months)
- Incidence of adverse events per dose level(for an average of 4 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study of ARGX-110 in Participants With Advanced MalignanciesNeoplasmsNCT01813539OncoVerity, Inc.99
招募中
1 期
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid TumorsBreast CancerProstate CancerColorectal CancerCancerAngiosarcomaPancreatic CancerLiver CancerNCT06440005Angiex, Inc.80
已完成
1 期
Arginase-1 Peptide Vaccine in Patients With Metastatic Solid TumorsNon Small Cell Lung CancerUrothelial CarcinomaMalignant MelanomaColorectal CancerOvarian CancerSquamous Cell Carcinoma of the Head and NeckMetastatic CancerBreast CancerNCT03689192Herlev Hospital13
已完成
1 期
AMG 172 First in Human Study in Patients With Kidney CancerRenal Cell AdenocarcinomaClear Cell Renal CarcinomaRenal Cell CarcinomaClear Cell Renal Cell CarcinomaNCT01497821Amgen37
已完成
1 期
Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid TumorsCancerNCT00705653Progen Pharmaceuticals46