EUCTR2016-003028-22-FR进行中（未招募）1 期
A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects with Advanced or Recurrent Tumors - A Phase I/II trial of intralesional administration of RGT100
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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. Male or female aged = 18 years
- •2. Subject with histologically or cytologically confirmed diagnosis of advanced or recurrent tumors (including lymphomas) for whom all standards treatments have been used or are not feasible or RGT100-PEI is a suitable treatment option and:
- •a. For Group A: has cutaneous, subcutaneous, or lymph node injectable tumors
- •b. For Group B: has injectable liver tumors or liver metastases
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •4. Life expectancy > 3 months as assessed by the Investigator
- •5. Adequate organ function:
- •a. Bone marrow function: Hemoglobin = 10 g/dL (pre-treatment transfusion allowed); lymphocyte count = 0.5 × 109/L; absolute neutrophil count = 0.5 × 109/L; platelet count = 75 × 109/L
- •b. Hepatic function: aspartate transaminase (AST) and alanine transaminase (ALT) = 2 × upper limit of normal (ULN) (3 × ULN in the case of liver metastases); bilirubin = 1.5 × ULN (2 × ULN in case of liver metastases)
- •c. Renal function: creatinine < 1.5 × ULN and/or creatinine clearance = 50 mL/min (Cockroft and Gault)
- •6. Negative serum pregnancy test within 2 weeks before first dose of study drug if the subject is a woman of childbearing potential. Subjects and subjects’ partners of childbearing potential must agree to use birth control consistently and correctly during the study and for at least 6 months after the last study drug application.
- •7. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and 1 separate injectable lesion with diameter = 1 cm but < 7 cm
- •8. Ability to provide written informed consent before any study drug-related screening procedures being performed
- •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 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Any tumor-directed therapy within 4 weeks before study treatment
- •2. Treatment with investigational drugs within 4 weeks before study enrolment
- •3. Systemic steroids at a dose of > 10 mg of prednisolone, > 2 mg of dexamethasone a day or equivalent, except topical (inhaled, topical, nasal) for the last 28 days and ongoing
- •4. Subjects with rapidly progressing disease (as determined by the Investigator)
- •5. Ongoing immune-related adverse events (irAEs) and/or AEs = grade 2 not resolved from previous therapies except vitiligo, stable neuropathy grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
- •6. Within 4 weeks of major surgery
- •7. Prior splenectomy
- •8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy
- •9. Primary or secondary immune deficiency
- •10. Active allergy requiring systemic medication or active infections requiring anti-infectious therapy
- •11. Seropositive (except after vaccination) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •12. Clinically significant cardiac disease including heart failure (New York Heart Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year before study entry
- •13. Dementia or altered mental status that would prohibit informed consent
- •14. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator
- •15. History of stroke, seizures, encephalitis, or multiple sclerosis
- •16. Gastric ulcer or inflammatory bowel disease or Crohn’s disease or ulcerative colitis in the last 6 months.
- •17. Active drug or alcohol abuse
- •18. Pregnant or breast feeding
研究者
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