A phase I/II, open label, multi-centre study to assess the safety, tolerability, and efficacy of MG010 in combination with sorafenib in subjects with solid tumours who have failed existing treatments.

Metagone Biotech Australia Pty Ltd0 个研究点目标入组 50 人开始时间: 2020年8月27日最近更新: 2020年8月31日

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 50

研究概览研究设计入排标准研究者记录与标识符相似试验

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.Age over 18 years
•2.For subject to be enrolled in cohort 1 of dose-escalation stage:
•Histologically confirmed diagnosis of advanced or metastatic solid tumors for which standard treatment is unavailable/ineffective/intolerable.
•3. For subject to be enrolled in additional cohorts of dose-
•escalation stage and dose expansion cohort: Histologically confirmed diagnosis of one of the following advanced or metastatic solid tumours for which standard treatment is unavailable/ineffective/intolerable:
•a.Non-small cell lung carcinoma
•b.Renal cell carcinoma
•c.Colorectal cancer, or
•d. Hepatocellular carcinoma with liver function of Child-Pugh Class A or B (score 7 only), who are resistant to sorafenib
•4.Disease progression within 6 months after most recent standard therapy
•5.ECOG performance status of less than or equal to 2
•6.Have at least one tumour lesion measurable in a unidimensional way with either spiral CT/PET or CT or MRI (in case of brain lesions) only according to Response Evaluation Criteria In Solid Tumours (RECIST 1.1)
•7.Adequate organ function within 14 days prior to enrolment, as defined below:
•a.Bilirubin less than or equal to x Upper Normal Limit (UNL)
•b.AST/ALT/ALP < 5 x UNL
•c.Polynuclear neutrophils greater than or equal to 1 500/mm^3
•d.Haemoglobin > 90g/L
•e.Platelets greater than or equal to 100 000/mm^3
•f.Serum Creatinine < 2 x UNL
•g.GFR > 30 mL/min
•8. .Adequate oral intake without the need for enteral or parenteral feeding
•9.Life expectancy > 3 months
•10.Ability to understand and willing to sign a written informed consent document and to comply with the study protocol
•11.Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, during the last study period and for the following 6 months after the last study drug intake. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
•12.No known or suspected allergy or hypersensitivity to sorafenib or any component of the excipients of MG010
•13.For subjects with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
•14. Subjects with a history of hepatitis C virus (HCV) infection must have been treated
•and cured. For subjects with HCV infection who are currently on treatment, they are
•eligible if they have an undetectable HCV viral load

排除标准

•1.Surgery (except biopsy) within 4 weeks before enrolment
•2.Received any chemotherapy, radiotherapy, targeted therapy or immunotherapy within 4 weeks prior to the enrolment
•3.Archived tumour tissue, biopsy tissue or blood sample not available/not suitable for analysis of pDAPKS308 expression
•4.History of additional malignancies, except non-melanoma skin cancer, in situ cancer of the cervix, or other solid tumours thathave been considered cured for > 3 years
•5.Participated in any other investigational trial, unless treatment in that trial has been discontinued at least 30 days prior to the enrolment
•6.Known or suspected allergy or hypersensitivity to any of the therapeutic agents to be administered during the study
•7.Uncontrolled concurrent illness including, but not limited to active infection, symptomatic congestive heart failure or cardiac arrhythmia
•8.Known to have hypertension (systolic BP>180mmHg or diastolic BP>110mmHg)
•9.Receiving inducers of CYP3A4 activity (for example, St. John’s wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone) or sensitive substrates of CYP1A2, 1B1, 2C8, and 2C19 (e.g. theophylline, duloxetine, alosetron or tizanidine) within 2 weeks prior to the enrolment
•10.Uncontrolled mental disease or psychotic manifestation that would prohibit compliance with the protocol, the understanding of the informed consent form or the ability to withdraw from the study
•11.Malabsorption problem that may affect absorption of sorafenib or MG010
•12.ActiveHIV, HBV or HCV infections
•13.Pregnancy or breast feeding

研究者

发起方

Metagone Biotech Australia Pty Ltd

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