EUCTR2010-020729-42-PL进行中（未招募）1 期
A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47 as a Monotherapy in Non-Squamous Non-Small Cell Lung Cancer Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female aged = 18 years old
- •2. Have histologically confirmed non-squamous NSCLC. (If available at the site, the paraffin-fixed biopsy sample will be provided to the Sponsor.)
- •3. Have at least a single measurable lesion in accordance with the RECIST v1.1 criteria
- •4. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 5. Have a life expectancy of = 3 months
- •6. Have adequate organ function as determine by the following criteria:
- •a. Absolute neutrophil count = 1.5 x 1000000000/L
- •b. Platelet count = 100 x 1000000000/L
- •c. Haemoglobin (HGB) = 9 g/dL
- •d. Creatinine clearance = 60 mL/min calculated using the Cockcroft-Gault Formula or serum creatinine = 1.5 x upper limit of normal (ULN)
- •e. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) = 3 x ULN, or < 5 x ULN if liver abnormalities are due to underlying malignancy
- •f. Total bilirubin = 1.5 x ULN.
- •Note: Blood transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of L-DOS47 is administered are not allowed.
- •7. Able to understand the information provided to them and to give written informed consent any study activities are conducted
- •8. Are willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •9. Are not pregnant and do not plan to become pregnant during the study. Females of childbearing potential must provide a negative pregnancy test within the screening period (Day -21 to 0) and agree to use adequate contraception during the study and for a period of 90 days following the last dose of study treatment. Male patients and their female partners of child-bearing potential must agree to each use an approved form of contraception during the study and for a period of 90 days following the last dose. Adequate contraception includes oral or injectable (depot) oestrogen, and/or progestogen, or selective oestrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device or double barrier method (e.g., condom and diaphragm or spermicidal gel). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilisation or hysterectomy at least 3 months before study start.
- •Pathway Specific Inclusion Criteria:
- •Staging of non-squamous NSCLC must be assessed according to TNM, 7th edition and based on computed tomography (CT) scan.
- •10. Patients are required to meet one of the following additional inclusion criteria:
- •a. Chemo-naïve Stage IIIb or IV non-squamous NSCLC who are not candidates for radiotherapy or who refused standard therapy.
- •b. Refractory Stage IIIb or IV non-squamous NSCLC.
- •(Staging of non-squamous NSCLC must be assessed according to TNM, 7th edition and based on computed tomography (CT) scan.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Patients will not be entered in the study for any of the following reasons:
- •1. Are pregnant or nursing mother
- •2. Have a prior history of other malignancies with the exception of non-melanoma skin cancer
- •3.Have known history of central nervous system (CNS) metastatic disease (previously treated or untreated)
- •4. Show evidence of active infection
- •5. Have received treatment in another clinical study within the 30 days before commencing study treatment or have not recovered from side effects of a study drug, except for alopecia
- •6. Have a serious uncontrolled medical condition
- •7. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive
- •8. Sustained QTc (the QT interval corrected for heart rate) with Fridericia's correction > 450 ms at Screening or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
- •9. Pre-existing peripheral neurophathy = CTC Grade 2
- •10. Have dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol
- •11. Are receiving chemotherapy during the 30 days before study start; receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start or have not recovered from all treatment related toxicities to Grade = 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.)
- •12. Are taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system
- •13. Are participating (or planning to participate) in any other clinical trial during this study.
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