EUCTR2014-000070-19-GB进行中（未招募）1 期
A Cancer Research UK Phase I Study of MOv18 IgE, a first in class chimeric IgE antibody against folate receptor-a, in patients with advanced solid tumours
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
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. Histologically or cytologically-proven advanced unresectable solid tumour of a type known to express FRa in a percentage of cases (see Protocol Section 1.4.2).
- •2. Archival tumour tissue expressing FRa (1+, 2+ or 3+ membrane staining on at least 5% of tumour cells by immunohistochemistry) using the BN3.2 antibody, based on the technique described by Lawson & Scorer, 2010).
- •3. Advanced disease for which no alternative therapy is felt to be appropriate.
- •4. Measurable disease or disease evaluable by tumour marker. Measurable disease is preferred for patients entering higher cohorts to facilitate efficacy assessments.
- •5. World Health Organisation (WHO) performance status of 0 or 1 (see Protocol Appendix 1) and a life expectancy of at least 12 weeks.
- •6. Haematological and biochemical indices within the ranges shown below. These measurements should be performed within 7 days before the first dose of MOv18 IgE (Day -7 to Pre-dose on Day 1). Measurements performed before Day -7 may be accepted by the CDD to demonstrate eligibility if repeat testing is logistically difficult for the patient and is not considered necessary medically in the opinion of the Investigator or CDD.
- •Laboratory Test Value required
- •Haemoglobin (Hb) = 9.0 g/dL
- •Absolute neutrophil count = 1.5 x 10^9/L
- •Platelet count = 100 x 10^9/L
- •Serum bilirubin 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT)
- •and aspartate aminotransferase (AST) = 2.5 x ULN unless raised due to liver mets in which case
- •up to 5 x ULN is permissible
- •Serum creatinine = 1.5 x ULN
- •7. Aged 16 years or over at the time consent is given.
- •8. Written (signed and dated) informed consent and capable of co-operating with treatment and follow-up.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-C) and investigational medicinal products during the previous 4 weeks, or 5 product half-lives before treatment.
- •2. Patients on beta-blockers and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or tricyclic anti-depressants/MAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE and for the duration of MOV18 IgE therapy.
- •3. Patients on bisphosphonates or treated with bisphosphonates in the last 18 months.
- •4. Ongoing toxic manifestations of previous treatments that have not resolved to Grade 1 or lower (other than alopecia of any grade or Grade 2 peripheral neuropathy).
- •5. Known brain metastases that have not been previously treated and been stable for at least 2 months.
- •6. Female patients who are able to become pregnant (or already pregnant or lactating). However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to either sexual abstinence* or to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom; have an intra-uterine device and condom; diaphragm with spermicidal gel and condom) effective at the first administration of IMP, throughout the study and for six months afterwards are considered eligible.
- •7. Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception at the first administration of IMP, throughout the study and for six months afterwards). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the foetus or neonate.
- •8. Major thoracic or abdominal surgery from which the patient has not yet recovered.
- •9. At high risk from the effects of anaphylaxis because of non-malignant systemic disease including active uncontrolled infection, cardiac failure, peripheral vascular disease, previous cerebrovascular accident (CVA), dyspnoea due to heart failure, extensive lung metastases, significant pleural effusions or other conditions.
- •10. History of laryngeal oedema, uncontrolled or high risk asthma (according to Global Initiative for Asthma (GINA) guidelines - see Protocol Appendix 7), or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the study at the investigator's discretion.
- •11. Patients with any congenital or acquired immunodeficiency syndrome or receiving immunosuppressive therapy (including any dose of systemic corticosteroids), or who are immunosuppressed post organ transplant. However, patients receiving inhaled corticosteroids and patients with a history of allergy (other than anaphylaxis) are eligible, as are patients with a history of auto-immune disease.
- •12. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- •13. Patients with baseline elevation in serum tryptase (indicating possible mastocytosis) or a positive baseline basophil activation test (indicating a hypothetical potential for anaphylaxis with MOv18 IgE).
- •14.Participating or planning to participa
研究者
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