EUCTR2010-019290-15-GB进行中（未招募）1 期
A Phase I/II, Open label, Dose Finding Study to Assess the Safety, Tolerability and Efficacy of IMCgp100, a Monoclonal T Cell Receptor anti-CD3 scFv Fusion Protein in Patients With Advanced Malignant Melanoma. - Not Applicable
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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
入选标准
- •1. Pathologically documented Stage IV malignant melanoma or
- •unresectable Stage III melanoma for which no standard effective therapy exists or for which an appropriate window exists between alternative therapeutic options. Patients for whom early treatment with vemurafenib is indicated e.g. rapidly progressing or symptomatic disease, are excluded from this trial.
- •2. Previous surgery (other than resection of skin metastases), radiotherapy, chemotherapy, immunotherapy or experimental therapy completed >4 weeks before and all adverse events resolved to = grade 1. In cases where localised radiotherapy has been applied, treatment with IMCgp100 can be commenced after a two week period.
- •3. HLA A2 positive.
- •4. = 18 years old.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status =1.
- •6. For patients in the Dose Expansion part only, measurable disease according to RECIST 1.1 criteria. Patients participating in the dose escalation arms only require aeessable disease.
- •7. Life expectancy >3 months.
- •8. Blood tests within the following parameters:
- •a. Platelet count =100 x 10e9/L
- •b. Haemoglobin =9g/dL (blood transfusion to achieve this level is permitted)
- •c. Calculated creatinine clearance =50 mL/min using the modified Cockroft- Gault equation
- •d. Neutrophil count =1x10e9/L
- •e. Lymphocyte count =0.5x10e9/L
- •9. Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 6 months following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile.
- •10. Male patients must be surgically sterile or willing to use a double barrier contraception method upon enrolment, during the course of the study, and for 6 months following the last study drug infusion.
- •11. Patients with a history of adrenal insufficiency, maintained on stable replacement dose corticosteroid (<10 mg/d prednisone or the equivalent) are eligible for treatment with IMCgp100, unless there is a past history of adrenal crisis. Eligible patients with a history of adrenal insufficiency receiving replacement dose corticosteroid must receive prophylactic stress dose corticosteroid prior to dosing during the first four doses of IMCgp100 treatment, regardless of weekly or daily dosing regimen.
- •12. Able to give 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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. Symptomatic brain metastases that are unstable, require steroids, or that have required radiation within the last 28 days.
- •2. Other active malignancy in the past 5 years except carcinoma in situ, completely excised non-melanomatous skin cancer or any other malignancy that in the opinion of the investigator is considered to be cured.
- •3. Comorbid medical condition that would increase the risk of toxicity in the opinion of the investigator or sponsor. Any symptomatic ongoing infection must be resolved before the patient can be treated in the study.
- •4. Uveitis
- •5. Had myocardial infarction within 1 year before enrolment, symptomatic congestive heart failure (New York Heart Association >Class II), unstable angina or unstable cardiac arrhythmia requiring medication.
- •6. Has an ejection fraction <50%.
- •7. Clinically significant electrocardiogram (ECG) changes that obscure the ability to assess the RR, PR and QT intervals. Patients with QTc calculated by Bazetts or locally preferred formula which is greater than 500ms.
- •8. Has hepatic function as follows:
- •- Aspartate aminotransferase >2.5 x upper limit of normal (ULN)
- •- Alanine aminotransferase >2.5 x ULN
- •- Bilirubin >2.0 x ULN
- •- Prothrombin time or partial thromboplastin time>1.5 x ULN
- •9. Bleeding diathesis.
- •10. Immunosuppressive condition or treatment including previous transplantation, splenectomy or known HIV infection.
- •11. Has a history of adult seizures.
- •12. Patients with evidence of a raised intracranial pressure in Arm2 of the study who will have a CSF sample taken
- •13. Patients receiving chronic corticosteroid treatment (longer than 8 weeks duration) for management of pre-existing adverse events at any dose, or patients with a history of chronic corticosteroid treatment longer than 8 weeks duration for adverse events within 6 months.
研究者
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