ACTRN12618000675224已完成1 期
Phase 1 open-label, dose escalation study of INB03 in patients with metastatic cancer with increased inflammatory biomarkers in peripheral blood
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
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 80 Years（—）
- 性别
- All
入选标准
- •1. Subject is greater than or equal to 18 years old, male or female.
- •2. Subject has histopathological diagnosis of epithelial cancer and meets the following criteria:
- •a. Diagnosed with stage 3 or 4 cancer of the lung, breast, upper or lower gastrointestinal
- •tract, kidney, or skin (melanoma only)
- •b. Diagnosed with cancer that is unlikely to clinically benefit from any other currently
- •available therapies.
- •c. There is no limit to the number of prior therapies allowed.
- •3. Subject has an hsCRP >10 mg/L that cannot be attributed to an infection.
- •4. Subject has a life expectancy > 4 months in the opinion of the Investigator.
- •5. Subject has adequate organ and marrow function (as defined below):
- •a. Serum creatinine less than or equal to 1.5 X upper limit of normal (ULN), or calculated creatinine clearance greater than or equal to 60 ml/min/1.73m2 as measured by Cockcroft-Gault
- •b. Aspartate aminotransferase and alanine aminotransferase levels less than or equal to 3 X ULN.
- •c. Total bilirubin < 1.5 X ULN, unless known diagnosis of Gilbert’s syndrome
- •d. Absolute neutrophil greater than or equal to 1,500/mm3
- •e. Platelet count greater than or equal to 50,000/mm3
- •f. Hemoglobin greater than or equal to 10 mg/dL (transfusion to obtain hemoglobin greater than or equal to 10 mg/dL within 24 hours prior to dosing is allowed)
- •6. Subject must be at least 4 weeks from previous therapy (eg, chemotherapy, hormonal therapy,
- •radiation therapy, immunotherapy and monoclonal antibodies, alternative therapy or
- •investigational therapeutic agents).
- •7. Subjects who have had major surgery must be fully recovered and require a recovery period of greater than or equal to 4 weeks prior to study Screening.
- •8. Subject must have an Eastern Cooperative Oncology Group performance status less than or equal to 2.
- •9. Subjects who are women of childbearing potential must not be pregnant and breastfeeding. Male and female subjects of childbearing potential must agree to use adequate contraception (barrier method or abstinence) for the duration of study therapy and for 3 months after the last dose of INB03. Any pregnancy that occurs for study participants should be monitored for potential side effects.
- •a. Women must discontinue any hormonal forms of birth control at least 4 weeks
- •prior to initiating the study.
- •10. Subject, or legal guardian, must be able to understand and voluntarily sign a written informed consent, and are willing and able to comply with the protocol requirements.
排除标准
- •1. Subject has sarcoma, haematological cancer or primary cancer of the central nervous system. Patients with brain metastasis from an epithelial cancer are eligible for treatment.
- •2. Subject has an active infection. Subjects may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics and hsCRP returned to baseline.
- •3. Subject is currently taking concomitant corticosteroids or other immunosuppressive drugs. (Note, inhaled steroids for asthma and chronic obstructive pulmonary disease is accepted)
- •4. Subject is currently taking concomitant thalidomide or a tumour necrosis factor (TNF) alpha- inhibitors.
- •5. Subject has a resting, room air oxygen partial pressure (PO2) < 90% at Screening.
- •6. Subject has impaired cardiac function or clinically significant cardiac disease including the following:
- •a. New York Heart Association grade III or IV congestive heart failure.
- •b. Myocardial infarction within the last 6 months prior to dosing with INB03
- •c. Impaired left ventricular ejection fraction (< 40%) as assessed according to institutional
- •7. Subject has human immunodeficiency virus infection or an active hepatitis C or hepatitis B virus infection.
- •8. Subject has any other condition or finding that in the opinion of the PI or Sponsor Medical Monitor may render the subject at excessive risk for treatment complications or may not be able provide evaluable outcome information.
- •9. Subject has shown lack of recovery of prior adverse events (AEs) to Grade less than or equal to 1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] v 5.0) (except alopecia) due to therapy administered prior to the initiation of study drug dosing by the time of study Screening. Stable persistent grade 2 peripheral neuropathy may be allowed as determined on a case-by-case basis at the discretion of the PI or Medical Monitor.
- •10. Subject has uncontrolled seizures as determined by the PI.
- •11. Subject concomitant use of complementary or alternative medication or other agents
- •(investigational therapeutic agents) will not be allowed without approval of a PI or
- •sub-investigator. Every effort will be made to maximize subject safety and minimize changes in chronic medications.
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