ACTRN12620000622909尚未招募1 期
A Phase 1, Single-Centre, Non-Randomised, Open-Labelled, 2-Arm, Single Dose study of Chimeric Anti-La/SSB Antibody (APOMAB) Conjugated with 89Zirconium-Label (89Zr-APOMAB) as a Theranostic Imaging Agent Using ImmunoPET/CT in Patients with Advanced Lung or Ovarian Cancer
Central Adelaide Local Health Network0 个研究点目标入组 18 人开始时间: 2020年5月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants are eligible if they meet all of the following inclusion criteria:
- •1.Signed informed consent
- •2.Age greater than or equal to18 years
- •3.ECOG performance status 0-1
- •4.Life expectancy of greater than or equal to12 weeks
- •5.Histologically confirmed, inoperable stage III or IV non-small cell lung cancer (NSCLC) or limited or extensive stage small cell lung cancer (SCLC) suitable for palliative platinum-based chemotherapy, OR
- •6.Histologically confirmed, FIGO stage III or IV high-grade serous ovarian cancer (HGSOC) suitable for palliative or neoadjuvant platinum-based doublet chemotherapy
- •7.Must have sufficient tumour tissue available for assessment of homologous recombination deficiency (HRD). If not, a fresh tumour biopsy may be required
- •8.At least one area of disease measurable by RECIST v1.1 on CT or MRI at baseline before study entry
- •9.Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
- •Estimated glomerular filtration rate (eGFR) of greater than or equal to 40mL/min as measured using the Cockroft Gault formula
- •Total bilirubin less than or equal to 1.5x the upper limit of normal (ULN)
- •ALT and AST less than or equal to 2.5x ULN (less than or equal to 5x ULN for participants with liver involvement of their cancer)
- •10.Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to follow any of these measures if not surgically sterile during the course of the trial
- •Total abstinence from sexual intercourse
- •Double barrier methods (e.g. cervical cap, condom, contraceptive sponge, diaphragm or vaginal ring).
- •Intrauterine device
- •Contraception is necessary for at least 7 weeks after receiving the study drug
- •This protocol covers both lung and ovarian cancer populations, however, all patients must meet all of the inclusion criteria listed above if they are to be deemed eligible to participate
排除标准
- •Participants are excluded if they meet any of the following exclusion criteria:
- •1.Pregnant or breastfeeding females.
- •2.Participants with prior exposure to any chimeric antibodies and mouse proteins will be excluded.
- •3.Known uncontrolled hyperthyroidism
- •4.Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-APOMAB
- •5.Exposure to any radiopharmaceutical within 30 days before the administration of 89Zr-APOMAB.
- •6.Diagnosis of systemic lupus erythematosis or Sjögren Syndrome or presence of antinuclear antigen (ANA) titre of = 1:160 or extractable nuclear antigen (ENA) antibodies
- •7.Women (with or without a systemic autoimmune disease) who have a history of giving birth to a child with congenital heart block
- •8.Grade = 2nd degree atrioventricular block on ECG
- •9.Psychiatric illness or social situations that could limit compliance to the study requirements
- •10.Participants unwilling or unable to provide written informed consent
- •11.In the opinion of the investigator, the participant is not suitable to receive 89Zr-APOMAB
研究者
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