NCT02199886终止1 期
A Phase I Single Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Tumor absorbed dose of 131I BIBH 1
研究概览
简要总结
Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in tumour to that of normal tissue in patients with non-small cell lung cancer and to measure human anti-human antibody (HAHA) concentrations.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary or secondary advanced non-small cell lung cancer
- •Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material
- •Karnofsky performance status of ≥ 70
- •Expected survival of ≥ 3 months
- •Greater than or equal to 18 years of age
- •Absolute granulocyte count ≥ 2.5 x 10**9/L
- •Lymphocyte count > 0.7 x 10**9/L
- •Platelet count ≥ 100 x 10**9/L
- •Serum Creatinine ≤ 2.0 mg/dl (0.20 mmol/L)
- •Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 3x upper limit of normal
- •Total bilirubin < 2 mg/dl or 34µmol (SI unit equivalent)
- •Ability to provide written informed consent
排除标准
- •Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases
- •Exposure to an investigational agent within four weeks of the BIBH 1 infusion
- •Patients that are not fully recovered from surgery. Because of the potential binding of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as evidenced by incomplete granulation, infection or localized edema are excluded
- •Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for nitrsoureas and/or mitomycin-C.)
- •Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment
- •Serious illness: e.g., active infections requiring antibiotics, bleeding disorders or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
- •Women who are breast-feeding or pregnant
- •Men and women of childbearing potential who are unwilling to utilize a medically acceptable method of contraception
- •Previous participation in this study
- •Patients who have autoimmune disease or hypertopic skin conditions that possibly over-express Fibroblast Activation Protein and may be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis and keloids.
- •Patients with unstable angina pectoris. Patients prescribed medication to control their angina pectoris must be on a fixed dose for at least 1 month prior to screening to be eligible for the trial.
- •Patients who experienced a myocardial infarction within 3 months of Screening.
研究组 & 干预措施
BIBH 1
Experimental
dose escalation: 0.5, 2, 10 or 20mg/m**2, 7 days prior to surgery
干预措施: BIBH 1 (Drug)
结局指标
主要结局
Tumor absorbed dose of 131I BIBH 1
时间窗: week 2
Number of patients with abnormal biodistribution for 131I BIBH 1
时间窗: up to day 30
Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC)
时间窗: up to 30 days
次要结局
- Concentration of human anti-human antibodies (HAHA)(up to day 30)
研究者
相似试验
已完成
1 期
Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical BenefitNeoplasmsNCT02211859Boehringer Ingelheim70
已完成
1 期
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.Healthy VolunteersNCT06414798AbbVie60
已完成
1 期
Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants.HealthyNCT01978652Biogen44
已完成
1 期
A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the BloodHealthyNCT05738291Boehringer Ingelheim67
进行中（未招募）
1 期
Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced MalignanciesUrinary Bladder NeoplasmTriple Negative Breast NeoplasmsHormone Receptor Positive, HER2-negative NeoplasmsHormone Receptor Positive, HER2-low NeoplasmsBreast NeoplasmsNon-Small-Cell Lung NeoplasmsOvarian NeoplasmAdvanced Solid TumorNCT04561362BicycleTx Limited329