ACTRN12617001181392终止1 期
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of A-337 in Patients with Advanced Solid Tumors
INC Research Pty Ltd0 个研究点目标入组 4 人开始时间: 2017年8月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
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
- Treatment
- 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
- •1. Histologically or cytologically confirmed advanced malignant solid tumor
- •that is refractory to, intolerant of, or for which no standard of therapy is available.
- •2. Advanced solid tumors that are known to widely express EpCAM, including
- •but not limited to colorectal cancer, gastric cancer, lung cancer, ovarian cancer and
- •prostate cancer.
- •3. At least one measurable tumor lesion as per RECIST criteria v1.1 defined as
- •having at least one dimension with a minimum size of 10 mm in the longest
- •diameter by CT or MRI scan for non-nodal lesions or > or equal to 15 mm in short axis for nodal lesions. Radiographic disease assessment at baseline can be performed up to 28
- •days prior to the first dose.
- •4. Adequate archival tumor tissue available or willingness to have a fresh
- •biopsy. A fresh pre-treatment biopsy is compulsory for the first six patients
- •enrolled at the expansion stage.
- •5. Age > or equal to 18 years
- •6. ECOG performance status < or equal to 2
- •7. Life expectancy of at least 3 months
- •8. Ability to understand the patient information and informed consent form.
- •9. Signed and dated written informed consent
排除标准
- •1. Inadequate hematologic function, defined by: Neutrophil count < 1,500/mm3
- •(= 1.5 x 10^9/L), Platelet count < 100,000/mm3 (= 100 x 10^9/L), White blood
- •cells (WBC) < 1,500/mm3 (3 x10^9/L), Hemoglobin < 9.0 g/dL at Screening.
- •2. Abnormal renal or hepatic function as defined by:
- •ALT and AST > 2 x ULN, in case of liver metastases 3 x ULN
- •Total bilirubin > 1.5 x ULN
- •Creatinine clearance < 50 ml/min calculated by the Cockroft-Gault formula
- •or modification of diet in renal disease (MDRD)
- •Coagulation: International Normalized Ratio (INR) < or equal to 1.6 (unless receiving
- •anticoagulation therapy). Subjects on full-dose oral anticoagulation must be on a
- •stable dose (minimum duration 14 days). If receiving warfarin, the subject must
- •have an INR < or equal to 3.0 and no active bleeding (ie, no bleeding within 14 days prior to
- •first dose of study drug). Subjects on low molecular weight heparin will be allowed.
- •3. Decompensated liver cirrhosis.
- •4. Subject with known central nervous system (CNS) metastases, unless
- •metastases are treated and stable for at least 4 weeks and the subject has not been
- •taking systemic steroids < or equal to 10mg prednisone/day or equivalent. Patients with
- •leptomeningeal disease or cord compression are excluded.
- •5. Any concurrent disease, medical or social condition that could affect
- •compliance with the protocol or interpretation of results as judged by the
- •investigator. In particular, patients with the following conditions are not allowed to
- •enter the study:
- •Active infection or known bacteremia
- •Known infection with human immunodeficiency virus (HIV) or chronic
- •infection with hepatitis B virus or hepatitis C virus
- •Severe dyspnea or pulmonary dysfunction or need for continuous supportive
- •oxygen inhalation
- •Insufficient cardiac function defined as NYHA (New York Heart Association)
- •Grade 3 or 4.
- •History of myocardial infarction or unstable angina within 6 months prior to
- •History of stroke or transient ischemic attack within 6 months prior to Day 1
- •Clinically significant cardiac arrhythmias, uncontrolled hypertension
- •SBP>180 mmHg and DBP>100 mmHg
- •History of autoimmune disease including, not limited to celiac
- •disease, diabetes mellitus type 1, inflammatory bowel disease, multiple sclerosis,
- •psoriasis, rheumatoid arthritis, and systemic lupus erythematosus.
- •6. Treatment with immune modulators including, but not limited to,
- •cyclosporine and tacrolimus within 2 weeks prior to enrollment; systemic steroids
- •< or equal to 10 mg prednisone or equivalent per day are allowed as well as ophthalmic,
- •inhaled or nasal steroids..
- •7. Pregnant, nursing women or women of childbearing potential who are not
- •willing to use effective forms of contraception during participation in the study and
- •at least three months thereafter. Positive pregnancy test (HCG) within 3 days prior
- •8. Male patients with partners of child-bearing potential who are not willing to
- •use effective contraception during the trial and for at least three months thereafter,
- •unless surgically sterile.
- •9. Any anti-cancer therapy, including chemotherapy, hormonal therapy,
- •biologic therapy, or radiotherapy within 4 weeks prior to initiation of study
- •treatment with the following exceptions:
- •Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists
- 另有 3 项未显示
研究者
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