EUCTR2012-004495-19-DE进行中（未招募）1 期
A Phase I/II Dose Escalation study of the tumor-targeting human L19-IL2 monoclonal antibody-cytokine fusion protein in combination with Dacarbazine for patients with metastatic melanoma.
Philogen S.p.A.0 个研究点目标入组 96 人开始时间: 2012年11月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 18-70 years of age, inclusive
- •2. Must have histologically or cytologically confirmed cutaneous metastatic melanoma (Stage IV). For the Phase II part only patients with Stage IV M1a or M1b will be enrolled.
- •3. Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as identified by CT or MRI scan within 28 days before the first study drug administration.
- •4. Baseline LDH within normal range.
- •5. Maximal 1 line of previous systemic treatment for metastatic disease (prior adjuvant melanoma therapy, e.g., IFNa, is permitted.
- •6. For women of childbearing potential, a negative pregnancy test within 72 hours prior to the first dose of study treatment.
- •7. Women with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 12 weeks after the last dose of study medication.
- •8. Men with reproductive potential must be willing to practice acceptable methods of birth control during the study and for up to 12 weeks after the last dose of study medication.
- •9. Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- •10. Life expectancy of at least three months.
- •11. Adequate organ function: serum creatinine = 1.5 x ULN, total bilirubin = 30 mM/L (or mg/dL, = 2.0 mg/dL), hepatic transaminases = 2.5 x ULN, alkaline phosphatase = 2.5 x ULN.
- •12. ANC count = 1.5 x 10^9/L, platelet count = 100 x 10
- •^9/L, hemoglobin > 9 g/dL.
- •13. Normal 12-lead ECG and normal bidimensional echocardiogram or MUGA.
- •14. All toxic effects of prior therapy must have resolved to grade =1 unless otherwise specified above.
- •15. Willing and able to give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Pregnant or breastfeeding female
- •2. Primary ocular melanoma
- •3. Primary mucosal melanoma
- •4. Use of any investigational or other anti-cancer drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of DTIC and L19-IL2.
- •5. Prior radiation to a target lesion, unless there has been clear progression of the lesion since radiotherapy.
- •6. A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
- •7. History or clinical evidence of brain metastases or leptomeningeal disease.
- •8. Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.
- •9. Treatment with DTIC within 6 months before start of study.
- •10. Treatment with Ipilimumab within 6 months before start of study.
- •11. Hypersensitivity to DTIC
- •12. Concomitant use of drugs known to alter cardiac conduction
- •13. Chronic use of corticosteroids used in the management of cancer or non-cancer-related illness.
- •14. Unstable or serious concurrent uncontrolled medical conditions.
- •15. Inadequately controlled cardiac arrhythmias including atrial fibrillation.
- •16. History of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- •17. Heart insufficiency > grade II NYHA criteria.
- •18. Uncontrolled hypertension
- •19. Ischemic peripheral vascular disease.
- •20. Active infection or incomplete wound healing.
- •21. History or evidence of active autoimmune disease.
- •22. Known history of allergy to intravenously administered proteins/peptides/antibodies.
- •23. History of organ allograft.
- •24. Major trauma including surgery within 4 weeks prior to entering the study.
- •25. Any underlying medical or psychiatric condition which in the opinion of the investigator will make administration of study drug hazardous or hinder the interpretation of study results (e.g., AE).
研究者
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