EUCTR2013-002755-15-BE进行中（未招募）1 期
A first-in-human dose escalation and dose finding phase I/II trial of IMAB027 in patients with recurrent advanced ovarian cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 99
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
- Female
入选标准
- •(1)Signed written informed consent
- •(2)Female patients =18 years of age, no upper age limit.
- •(3)Histologically or cytologically confirmed CLDN6+ ovarian cancer of any histology type including primary peritoneal or fallopian tube tumors (histological documentation of the original primary tumor is required via a pathology report) that are either:
- •Patients with symptomatic recurrence
- •Primary-refractory to platinum therapy (as evaluated after at least 2 cycles of platinum-containing therapy); OR
- •Platinum-resistant population: relapsed <6 months after platinum-therapy; OR
- •Patients with recurrence after =2 lines of standard therapy of which at least one is platinum-based OR
- •Patients with asymptomatic recurrence
- •Patients with asymptomatic disease in progression detected by increase of CA125 levels according to GCIG criteria during systematic follow-up (CA125-rise” patients), who had at least one line of standard treatment
- •(4)Performance status ECOG 0-2
- •(5)Patients with measurable, non-measurable, or evaluable disease:
- •Evaluable disease: defined as a confirmed CA-125 =2 x ULN
- •Measurable disease (RECIST 1.1): defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
- •Non-measurable disease: includes patients with symptomatic ascites or pleural effusions, lesions that do not meet RECIST 1.1 criteria or biopsy proven recurrence. Patients with clinically evident non-measurable disease must have either an elevated CA125 or histological confirmation of recurrence
- •(6)Availability of a FFPE tumor tissue sample or tumor cell positive paracentesis fluid samples (abdominal- or pleural cavity) for the assessment of CLDN6 positivity
- •(7)Life expectancy of >12 weeks
- •(8)Adequate organ function defined as:
- •Adequate hematologic function (ANC =1000/µl, platelets =100.000/µl, hemoglobin =8.5 g/dl [5.6 mmol/l] (can be post transfusion))
- •Adequate renal function (serum creatinine =1.5 mg/dl [114.5 µmol/l] or creatinine clearance rate =30 ml/min)
- •Adequate liver function (serum total bilirubin =2 x ULN, AST/ALT =3 x ULN)
- •(9)Patients of child-bearing potential must have a negative ß-HCG urine test within 72 hours before receiving treatment
- •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 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •(1)Patient is pregnant or breast-feeding
- •(2)Prior allergic reaction or intolerance to a monoclonal antibody (humanized or chimeric)
- •(3)Any prior anti-tumor therapy within 14 days prior to the start of IMAB027 treatment
- •(4)Other concurrent anticancer therapies
- •(5)HIV infection in medical history or active, medicinally not well controlled Hepatitis B or C infection
- •(6)History of any one or more of the following cardiovascular conditions within the past 6 months:
- •Myocardial infarction (T-Wave/Non-T-Wave)
- •Unstable angina pectoris
- •Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
- •History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT). Patients with recent DVT who have been or are treated with therapeutic anti-coagulant agents (excluding warfarin) for at least 6 weeks are eligible
- •(7)Other investigational agents or devices concurrently or within 14 days before start of IMAB027 treatment. If half-life of prior investigational agent is >7 days, distance to prior investigational agent should be at least two half-lives. Patients with prior radiotherapy are allowed, if discontinued at least 14 days prior to the first dose of study medication. Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
- •(8)Any hemoptysis or bleeding event that is clinically relevant within 2 weeks of first dose of study drug
- •(9)Clinical symptoms of brain metastases or tumor-associated spinal cord compression.
- •(10)Need for continuous, systemic immunosuppressive therapy. Concurrent systemic immunosuppressive therapy, in particular systemic corticoids must be stopped 2 weeks prior first treatment. Inhaled and topically applied steroids are allowed. Systemic steroids should be avoided as long as patient is under study medication.
- •(11)Any other medical condition that would, in the opinion of the Investigator, limit the patient’s ability to complete the study.
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