NL-OMON52685招募中不适用
First-in-human Phase I dose escalation study assessing safety, tolerability and preliminary efficacy of immunomodulatory nanoparticles - PRECIOUS-01
Tumor Immunology0 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
- 招募中
- 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. Age >=18 years at time of signing informed consent.
- •2. Performance status (ECOG <= 1) (Appendix II).
- •3. Estimated life expectancy of at least 6 months.
- •4. Histologically or cytologically confirmed advanced and /or metastatic solid
- •tumor with progressive disease at baseline, for whom no standard treatment is
- •available. Suitable solid tumor indications include non-small cell lung cancer
- •(NSCLC), melanoma, epithelial ovarian cancer, bladder cancer, breast cancer,
- •and synovial sarcoma, adenoid cystic carcinoma, cervical cancer, endometrial
- •cancer, lung cancer, pancreatic cancer, prostate cancer, myxoid and round cell
- •liposarcoma, neuroblastoma, vulvar cancer, esophageal cancer, hepatocellular
- •cancer, and head and neck cancer.
- •5. Subject with evaluable disease per RECIST v1.1.
- •6. Adequate hematologic, renal and liver function as defined by laboratory
- •values performed within 14 days of start of treatment:
- •a. Hemoglobin (Hb) >= 6 mmol/L;
- •b. Absolute Lymphocyte Count (ALC) > 0.8 x 109/L;
- •c. Absolute Neutrophil Count (ANC) >= 1.5 × 109/L;
- •d. Platelet count > 100 x 109/L;
- •e. Serum creatinine <= 1.5 x ULN or calculated creatinine clearance >= 60 mL/min
- •(as determined by MDRD [Modification of Diet in Renal Disease]) for patients
- •with serum creatinine levels > 1.5 x ULN;
- •f. Serum bilirubin < 25 µmol/L;
- •g. Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= ULN
- •unless related to liver metastasis (in which case levels should be < 3 x ULN).
- •h. Alkaline Phosphatase (ALP) <= ULN unless related to liver or bone marrow
- •metastases (in which case levels should be <= 3 x ULN).
- •7. Previous therapy-derived toxicities should be resolved to Grade < 2
- •according to CTCAE v5.0 (Appendix I), with exceptions for alopecia.
- •8. All subjects of childbearing potential (defined as < 2 years after last
- •menstruation or not surgically sterile) must have a negative highly sensitive
- •pregnancy test at screening (urine/serum) and agree to use a highly effective
- •method for contraception according to the EU Clinical Trial Facilitation Group
- •guidance from time of signing the informed consent form (ICF) until at least
- •120 days after the last administration of PRECIOUS-01. The partners of subjects
- •with childbearing potential must also apply contraceptive methods, and are
- •recommended not to donate sperm.
- •9. Before registration, ability of subject to give written informed consent
- •according to International Council for Harmonisation (ICH) Good Clinical
- •Practice (GCP), and national rules/local regulations.
- •10. Expected adequacy of follow-up.
排除标准
- •1. Second malignancy in the previous 2 years, with the exception of adequately
- •treated in situ carcinoma of the cervix uteri and basal or squamous cell
- •carcinoma of the skin,
- •2. Clinical suspicion or radiological evidence of active brain metastases.
- •Patients with brain metastases that have been treated previously and are proven
- •stable (computed tomography [CT] or magnetic resonance imaging [MRI] < 30 days)
- •and without steroids for > 3 months are allowed.
- •3. Subjects with thromboembolic events within the past year.
- •4. Subjects suffering from melanoma, non-Hodgkin lymphoma, or renal cell
- •carcinoma who have a serum Lactic Acid Dehydrogenase (LDH) > ULN.
- •5. Subjects on any other anticancer therapy (cytotoxic, biologic or
- •investigational agents), unless at least 4 weeks (or 5 half-lives, whichever is
- •shorter, 6 weeks for mitomycin-C or nitrosoureas), have elapsed since the last
- •dose before the first administration of PRECIOUS-01. At least 4 weeks should
- •have elapsed since receiving palliative radiotherapy. Chronic treatment with
- •non-investigational gonadotropin-releasing hormone analogs or other hormonal or
- •supportive care is permitted.
- •6. Subjects with major surgery within 4 weeks before initiating treatment or
- •with minor surgical procedure within 7 days before initiating treatment (except
- •for port-a-cath or central line i.v. placement, or biopsy), or anticipation of
- •the need for major surgery during the course of the trial treatment.
- •7. Concomitant use of oral or i.v. immunosuppressive drugs. Inhaled, topical or
- •intranasal steroids and adrenal replacement steroids < 10 mg/day (prednisone
- •equivalent) are permitted in the absence of auto-immune disease.
- •8. Uncontrolled infectious disease, i.e., negative testing for human
- •immunodeficiency virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)
- •and syphilis (Treponema Pallidum Hemagglutination Assay [TPHA]).
- •9. (Systemic) autoimmune disease such as, but not limited to, inflammatory
- •bowel disease, multiple sclerosis and lupus. Subjects with type 1 diabetes
- •mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders
- •(eczema and psoriasis) are not excluded.
- •10. History of clinically significant cardiovascular disease (<= 6 months prior
- •to Day 1 on trial) such as stroke, Transient Ischemic Attack (TIA), unstable
- •angina, New York Heart Association (NYHA) Grade II or greater congestive heart
- •failure, myocardial infarction, uncontrolled hypertension, cardiac arrhythmia
- •requiring medication, relevant pathological ECG findings or uncontrolled
- •hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg).
- •11. Serious (bleeding and clotting) condition(s) that may interfere with safe
- •administration of PRECIOUS-01.
- •12. Abnormal or clinically significant coagulation parameters at the discretion
- •of the Clinical Investigator, i.e.:
- •a. Prothrombin Time - International Normalized Ratio (PT-INR)
- •b. Activated Partial Thromboplastin Time (APTT)
- •c. Subjects being treated with anticoagulants are excluded if the coagulation
- •parameters are outside the therapeutic intervals as described in the Summary of
- •Product Characteristics (SmPC) for the administered treatment.
- •13. Evidence of any other conditions (such as psychological/familial
- •sociological/geographical issues, psychiatric illness, infectious diseases,
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