A phase I/IIa, multicentre, open label study designed to evaluate the safety and tolerability of escalating doses of AGI-134 in unresectable/metastatic solid tumours. - Safety and Tolerability of AGI-134

Agalimmune Ltd.0 个研究点目标入组 55 人开始时间: 2018年11月7日最近更新: 2020年6月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Agalimmune Ltd.
入组人数: 55

研究概览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

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.Adult male or female aged 18 years old or older.
•2.Have a histologically or cytologically confirmed unresectable metastatic solid tumour and who have received, or been intolerant to, all curative treatment options and treatments demonstration to prolong survival.
•3.Subjects should have at least two measurable lesions based on RECIST v1.1 as determined by the site study team. Tumour lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. At least two lesions with the following characteristics are needed to be eligible:
•Part 1: Unresectable superficial/palpable tumour feasible for intratumoural injection from any solid tumour, and a metastatic/secondary lesion that can be assessed for abscopal effect and from which a biopsy can be taken.
•Part 2: An unresectable lesion feasible for Intratumoural injection from any type of unresectable metastatic solid tumour including deep lesions, and a metastatic/secondary lesion that can be assessed for abscopal effect and from which a biopsy can be taken
•4.Subjects who are willing to undergo tumour biopsies, unless tumour is considered inaccessible or biopsy is otherwise considered not in the subject's best interest.
•5.Tumour size:
•Part 1: the total size of the tumour(s) should allow injection of the total volume required at each escalation cohort. The volume can be injected in one lesion or divided into more than one lesion, but the total volume should be given according to the total dose at each escalation part. When volume is divided between several tumours, at least 1 mL should be injected into each tumour.
•Part 2: tumour dimensions should allow injection of a minimum of 1 mL AGI-134, in one lesion or more, hence the total tumour dimensions (from one or more lesions) should be of at least 1.5 cm for longest dimension.
•6.Has = 2 lesions; =1 injectable lesion which is amenable to injection and biopsy and is measurable according to RECIST v1.1, and =1 metastatic lesion which is amenable for biopsy and measurable according to RECIST v1.1.
•7.Evaluable Disease according to RECIST v1.1
•8.Has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
•9.Has a life expectancy >3 months.
•10.Adequate organ function at Screening as defined below. All laboratory assessments should be performed within 10 days prior to treatment initiation
•Haematology:
•?White blood cell (WBC) = 2,500/mm3
•?Absolute neutrophil count = 1500 /mm3
•?Platelet count = 100,000/mm3
•?Haemoglobin =9 g/dL or =5.6 mmol/L
•?Haematocrit =30%
•Renal function:
•?Creatinine =1.5x Upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR]) can also be used in place of creatinine or CrCl) > 50 mL/min for subject with creatinine levels > 1.5x institutional ULN
•Hepatic function:
•?Total Bilirubin: =1.5xULN OR Direct bilirubin =ULN for subjects with total bilirubin levels >1.5xULN
•?AST (SGOT) and alanine aminotransferase (ALT) (SGPT): =2.5xULN OR =5xULN for subjects with liver metastases
•Coagulation:
•?International Normalised Ratio (INR) or Prothrombin Time (PT): =1.5xULN unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants
•?Activated Partial Thromboplastin Time (aPTT): =1.5xULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagula

排除标准

•Subject must be excluded from participating the study if he/she:
•1.Has a disease that is suitable for therapy administered with curative intent.
•2.Has any active, acute, or chronic infection(s) that are uncontrolled and/or requiring treatment, such as antibiotics
•3.An active autoimmune disease that has required systemic treatment in the 2 years preceding the study (i.e., with the use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
•4.History of or plan for splenectomy or splenic irradiation
•5.History of organ transplant or currently taking active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
•6.Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
•7.Has known active Hepatitis B (e.g., Hepatitis B Surface Antigen [HBsAg] reactive) or Hepatitis C (e.g., Hepatitis C Virus [HCV] RNA [qualitative] is detected).
•8.Has known Chronic Hepatitis B or C.
•9.History or evidence of cancer associated with immunodeficiency states (e.g. hereditary immune deficiency, organ transplant, or leukaemia)
•10.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
•11.Is expected to require any other form of antineoplastic therapy while on study.
•12.Had received live vaccines within 30 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chickenpox, yellow fever, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
•13.Has positive IgE anti -Gal
•14.Subject has a known allergy to alpha-Gal, such as red meat allergy, exposure to lone star tick (Amblyomma americanum), Ixodes ricinus/holocyclus, or Cetuximab allergy
•15.Has known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product
•16.History or evidence of central nervous system metastases and/or carcinomatous meningitis (unless stable without treatment for at least 6 weeks and not requiring steroids)
•17.Has received other experimental therapies or used an investigational device within 28 days of the first dose of treatment
•18.Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to study Day 1 or has not recovered from AE> Grade 1 by treatment administered more than 14 days before first dose
•19.Has had a prior anti-cancer monoclonal antibody (mAb) within 28 days prior to study Day 1 or who has not recovered from AE > Grade 1 by treatment administered more than 28 days earlier.
•20.Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 120 days after the last dose of study treatment. Women with a positive pregnancy test within 72 hours from Baseline.
•21.Has unstable angina, new onset angina within the last 3 months, myocardial infarction within the last 6 months, uncontrolled atrial fibrillation, or current congestive heart failure with New York Heart Association Class III or higher.
•22.Has a known current additional malignancy th

研究者

发起方

Agalimmune Ltd.

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