NL-OMON53493尚未招募不适用
A Phase 1a/1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients with Solid Tumour Malignancies to Evaluate GEH200520 Injection / GEH200521 (18F) Injection Safety and Tolerability, Positron Emission Tomography Imaging, Pharmacokinetics, and Changes in Imaging after Treatment - GEH200520/GEH200521(18F) used for PET scans in patients with solid tumors
GE Healthcare Ltd.0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
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
- 年龄范围
- 18 至 99（—）
入选标准
- •(1) The subject is able and willing to comply with all study procedures as
- •described in the protocol, including the imaging day pre-visit requirements,
- •and has read, signed, and dated an informed consent form prior to any study
- •procedures being performed.
- •(2) The subject is male or female, >=18 years of age.
- •(3) Subject has a body mass index (BMI) >=18 and <=30 kg/m2.
- •(4) Subject has a life expectancy >=12 weeks.
- •(5) Subject has Eastern Cooperative Oncology Group (ECOG) performance status
- •(6) Subject has an irresectable or metastatic solid tumour or a local and
- •resectable head and neck squamous cell carcinoma.
- •(7) Subject is eligible for ICI treatment.
- •(8) Subject has at least 1 measurable tumour lesion documented on CT/magnetic
- •resonance imaging (MRI) RECIST v1.1 during the last 12 months. Previously
- •irradiated lesions should not count as target lesions.
- •(9) Subject has a tumour lesion(s) of which a biopsy can safely be obtained
- •according to standard clinical care procedures.
- •(10) Subject is male, or a female who is either surgically sterile (has had a
- •documented bilateral oophorectomy and/or documented hysterectomy),
- •postmenopausal (cessation of menses for more than 1 year), or non-lactating, or
- •if of childbearing potential the results of a serum or urine human chorionic
- •gonadotropin pregnancy test, at screening and on the day of IMP administration
- •(with the result known before IMP administration), must be negative. Women of
- •childbearing potential and males who are sexually active with a partner of
- •childbearing potential must use adequate contraception from Screening until 30
- •days after IMP administration. Such methods include: hormonal contraception
- •including oral contraceptives; intrauterine device; intrauterine
- •hormone-releasing system; bilateral tubal occlusion; vasectomised partner;
- •sexual abstinence; adequate barrier method with spermicide (e.g., diaphragm,
排除标准
- •(1) Subject is unable to undergo all procedures in the study and/or is unable
- •to remain still and tolerate the imaging procedure.
- •(2) Subject has 12-lead ECG significant findings during screening, per
- •Investigator*s assessment.
- •(3) Subject is not stable due to medical condition or therapy that, in the
- •opinion of the Investigator, could compromise subject safety or protocol
- •objectives.
- •(4) Subject has active autoimmune disease or a documented history of autoimmune
- •disease or syndrome that requires systemic steroids or immunosuppressive agents.
- •(5) Subject has a confirmed active COVID-19 infection.
- •(6) Subject has serious non-malignant disease or conditions that, in the
- •opinion of the Investigator, could compromise subject safety or protocol
- •objectives.
- •(7) Subject has B or T cell lymphoma.
- •(8) Subject has brain or bone-marrow metastasis that, in the opinion of the
- •Investigator, could compromise subject safety or protocol objectives.
- •(9) Subject has signs or symptoms of systemic infection within 2 weeks prior to
- •imaging day.
- •(10) Subject has history of severe allergic, anaphylactic, or other
- •hypersensitivity reactions to chimeric or humanised antibodies or fusion
- •proteins or known allergy to the study IMP ingredients and/or the proposed ICI
- •(11) Subject has any other diseases, metabolic dysfunction, physical
- •examination finding, or clinical laboratory finding giving reasonable suspicion
- •of a disease or condition that contraindicates the use of the ICI treatment, or
- •that may affect the interpretation of the results or render the subject at high
- •risk from complications.
- •(12) Subject has laboratory values of:
- •I. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater
- •than 3 times the upper limit of normal (ULN) or greater than 5 times the ULN in
- •case of liver metastases.
- •II. Bilirubin >3.0 x ULN
- •III. Creatinine clearance <45 mL/min/1.73 m2
- •IV. Leukocyte count <3,500/mm3
- •V. Platelet count <100,000/µL
- •(13) Subject has any safety laboratory test results (clinical chemistry,
- •haematology, and urinalysis) that, in the opinion of the Investigator, could
- •compromise subject safety or protocol objectives.
- •(14) Subject has had any major surgery within 4 weeks prior to enrolment or
- •major surgery is scheduled during the study, with the exception of procedures
- •that are part of the study site IIS.
- •(15) Subject has been enrolled in another interventional clinical study within
- •the 30 days before screening for this study, except for the study site IIS.
- •(16) Subject is pregnant or planning to become pregnant or is lactating.
- •(17) Subject has a history of alcohol or drug abuse within the last year.
- •(18) Subject has had treatment with systemic immunostimulatory agents
- •(including but not limited to interferons [IFNs] or interleukin-2 [IL-2])
- •within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to
- •dosing with the IMP.
- •(19) Subject has had treatment with systemic immunosuppressive medications
- •(including but not limited to prednisone, cyclophosphamide, azathioprine,
- 另有 4 项未显示
研究者
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