NL-OMON51802尚未招募不适用
A Phase 1 Study to Determine the Safety, and Pharmacokinetics of the Selective MET kinase Inhibitor, DO-2 in Patients With Advanced or Refractory Solid Tumours - Phase 1 study of DO-2 in solid tumours
DeuterOncology NV0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
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. 18 years or older
- •2. histologically or cytologically confirmed advanced or refractory solid
- •tumour and no longer eligible for approved, available standard therapies.
- •Tumour types must have:
- •a. proven MET activating mutations, determined by previous next generation
- •sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing
- •(WTS) or other genomic analysis methods,
- •b. proven amplification (>= 10 copies) on archived tumour tissue.
- •c. Hereditary Renal Papillary Cancer
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of <= 2
- •4. adequate bone marrow function, without the support of cytokines: white blood
- •cell count (WBC) >3,000/mm3, absolute neutrophil count (ANC) >1,500/mm3,
- •platelet count >100,000/mm3, hemoglobin >10 g/dL
- •5. adequate liver function: total bilirubin level <= 1.5 x institutional upper
- •limit of normal (ULN), alanine aminotransferase (ALT) and aspartate
- •aminotransferase (AST) <= 2.5 x institutional ULN in the absence of liver
- •metastasis, or <= 5.0 x institutional ULN in the presence of liver metastasis
- •6. adequate renal function with serum creatinine <= 1.5 x institutional ULN and
- •GFR of 60mL/min or higher by Cockroft-Gault formula. See Attachment 1.
- •7. agree to follow the contraception requirements of the trial as described in
- •section 4.4.
- •8. signed informed consent, indicating study patients understand the purpose of
- •and procedures required for the study and are willing to participate in the
排除标准
- •1. major surgery within 3 weeks before enrollment
- •2. chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks),
- •radiotherapy, immunotherapy, or any other study drug within 3 weeks before
- •study drug administration
- •3. antibody based cancer therapy within 4 weeks before administration of the
- •first dose of DO-2
- •4. patients with brain metastases are excluded unless all of the following
- •criteria are met:
- •a. CNS lesions are asymptomatic and previously treated
- •b. No ongoing requirement for corticosteroids as therapy for CNS metastases
- •c. Imaging demonstrates stability of disease >= 28 days from last treatment for
- •CNS metastases
- •5. leptomeningeal involvement (leptomeningeal carcinomatosis)
- •6. history of uncontrolled heart disease including unstable angina, congestive
- •heart failure, myocardial infarction within preceding 12 months, clinically
- •significant rhythm or conduction abnormality, congenital long QT syndrome,
- •obligate use of a cardiac pacemaker, QTc at screening greater than 450
- •milliseconds in males and greater than 470 milliseconds in females.
- •7. uncontrolled arterial hypertension: systolic blood pressure of 160 mmHg or
- •greater or diastolic blood pressure of 100 mmHg or greater or both, despite
- •appropriate therapy.
- •8. positive pregnancy test (urinary beta hCG) at screening (applicable to women
- •of child-bearing potential who are sexually active)
- •9. mental status alteration or history of major psychiatric illness, which may
- •potentially impair patient*s compliance with study procedures
- •10. signs and symptoms of active infection requiring systemic therapy
- •11. other medical condition (e.g. pre-existing kidney dysfunction) that in the
- •opinion of the investigator makes it undesirable for a patient to participate
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