EUCTR2015-000896-28-DE进行中（未招募）1 期
A Phase 2a Randomized, Open-label Study to Assess the Safety, Tolerability, and Efficacy of BAX69 in Combination with 5-FU/Leucovorin or Panitumumab versus Standard of Care in Subjects with Metastatic Colorectal Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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. Provision of a signed informed consent
- •2. Male and female subjects 18 years of age and older at the time of screening
- •3. Subjects who progressed after receiving at least 2, but no more than 3, prior cancer drug therapy treatment lines including SoC in the metastatic setting.
- •4. Anticipated life expectancy > 3 months at the time of screening
- •5. Weight between 40 kg and 180 kg
- •6. Histologically or cytologically confirmed diagnosis of CRC
- •7. Metastatic CRC not amenable to surgical resection
- •8. Known KRAS, NRAS mutation status (if unknown status for either of these genes, and no archival tissue is available, a fresh tumor biopsy will be obtained)
- •9. At least 1 measurable lesion as defined by RECIST v1.1
- •10. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
- •11. Adequate hematological function, defined as:
- •a. Platelet count = 100,000/µL
- •b. Prothrombin time and activated partial thromboplastin time (aPTT) < 1.5 times the upper limit of normal (ULN)
- •c. Absolute neutrophil count = 1,000/µL
- •d. Hemoglobin = 9 g/dL, without the need for transfusion in the 2 weeks prior to screening
- •12. Adequate renal function, defined as serum creatinine = 2.0 times ULN and creatinine clearance > 50 mL/min or eGFR estimated glomerular filtration rate > 50ml/min/1.73 m2
- •13. Adequate liver function, defined as:
- •a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times ULN for subjects without liver metastases, or = 5 times ULN in the presence of liver metastases
- •b. Bilirubin = 2.0 times ULN, unless subject has known Gilbert’s syndrome
- •14. Adequate venous access
- •15. For female subjects of childbearing potential, the subject presents with a negative serum pregnancy test at screening and agrees to employ 2 forms of adequate birth control methods, including at least 1 barrier method (eg, diaphragm with spermicidal jelly or foam, or [for male partner] condom) throughout the course of the study and for at least 90
- •days after the last administration of imalumab. In addition, these birth control methods must be continued for at least 180 days after last administration of 5-FU in subjects who receive this treatment. Secondary contraceptive measures could be either birth control pills, patches, or intrauterine devices
- •16. For male subjects, they must agree to use adequate contraceptive measures including at least 1 barrier method (eg, condom with spermicidal jelly or foam and [for the female partner] diaphragm with spermicidal jelly or foam, birth control pills/patches, or intrauterine device) and abstain from sperm donation throughout the course of the study and for at least 90 days after the last administration of imalumab. In addition, these birth control methods must be continued for at least 180 days after last administration of 5-FU in subjects who receive this treatment
- •17. Subject is willing and able to comply with the requirements
- •of the protocol
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Known central nervous system metastases
- •2. Prior malignancy(s) within the past 3 years, with the exception of curatively treated basal or
- •squamous cell carcinoma of the skin, locally advanced prostate cancer, ductal carcinoma in situ of
- •breast, in situ cervical carcinoma and superficial bladder cancer
- •3. Prior treatment with panitumumab for subjects with KRAS/ wt and NRAS tumors
- •4. Known history of keratitis, ulcerative keratitis, or severe dry eye in subjects with KRAS wt and NRAS wt tumors.
- •5. Residual adverse event (AE) from previous treatment > Grade 1, except neuropathy and alopecia.
- •6. Myocardial infarction within 6 months prior to Cycle 1 Day 1 (C1D1), and/or prior diagnoses of
- •congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable
- •cardiac arrhythmia requiring medication; and/or the subject is at risk for polymorphic ventricular
- •tachycardia (eg, hypokalemia, family history, or long QT syndrome)
- •7. Uncontrolled hypertension defined as systolic blood pressure = 160 mmHg and/or diastolic blood
- •pressure = 100 mmHg confirmed upon repeated measures
- •8. Left ventricular ejection fraction (LVEF) < 40% as determined by echocardiogram performed at
- •screening or within 90 days prior to C1D1
- •9. Left ventricular ejection fraction (LVEF) < 40% as determined by (echocardiogramECHO)/multigated acquisition scan (MUGA) performed at screening or within 90 days prior to C1D1.
- •10. Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted
- •therapy, retinoid therapy, or hormonal therapy), within 4 weeks (< 28 days) prior to C1D1
- •11. Prior anti-tumor therapy (chemotherapy, radiotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, or hormonal therapy,) within 4 weeks (< 28 days) prior to C1D1
- •12. Major surgery within 4 weeks (< 28 days) prior to C1D1
- •13. Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints (osteoarthritis is not exclusionary)
- •14. Active infection involving IV antibiotics within 2 weeks prior to C1D1
- •15. Known history of, or active hepatitis B virus (HBV,) and/or hepatitis C virus (HCV), or active tuberculosis.
- •16. Known history of human immunodeficiency virus (HIV) type 1/2 or other immunodeficiency disease
- •17. Subject has received a live vaccine within 4 weeks (< 28 days) prior to C1D1
- •18. Known hypersensitivity to any component of recombinant protein production by Chinese Hamster Ovary (CHO) cells
- •19. Exposure to an investigational product or investigational device in another clinical study within 4 weeks (< 28 days) prior to C1D1, or is scheduled to participate in another clinical study involving an investigational product or device during the course of this study
- •20. Subject is breastfeeding or intends to begin breastfeeding during the course of the study
- •21. Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study
- •22. Subject is a family member or employee of the investigator
研究者
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