EUCTR2019-004819-31-BG进行中（未招募）1 期
A Phase I/II, multi-centre, open-label, adaptive design, umbrella study assessing the safety, tolerability, immunogenicity and efficacy of IN01 in combination with small-molecule inhibitors in two cohort of patients with either constitutively RAS or BRAF mutated unresectable metastatic colorectal cancer eligible for second line treatment. - CRAcIm 1
IN3BIO0 个研究点目标入组 70 人开始时间: 2021年3月19日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
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. Male and female patients, 18 years of age or older
- •2. With unresectable metastatic (stage IV) histologically or cytologically confirmed adenocarcinoma of the colon or the rectum
- •3. With at least one constitutive mutation in K or N RAS exon 2 codon 12 or 13, exon 3 codon 59 or 61, or exon 4 codon 117 or 146, or with a constitutive BRAFv600E. mutation (The mutation must have been identified on a tissue biopsy obtained before the first-line treatment or at the first-line treatment starts.)
- •4. Whose disease progresses after first line cancer treatment regimen
- •5. Able to take oral medication
- •6. With eastern cooperative oncology group (ECOG) performance status of = 1 and at least 3 months of expected survival
- •7. With a baseline lymphocyte count = 1 G/L (1,000/mm3)
- •8. Who agree to take appropriate precautions to avoid pregnancy/fathering a child from screening to 4 weeks after end of study treatment (males and females alike; except for postmenopausal women for at least 1 year [i.e., spontaneous amenorrhea at least 1 year prior to first IMP administration and confirmed follicle stimulating hormone [FSH] level >40 IU/L], or surgically sterile patients for at least 6 weeks; See 4.2 for more details).
- •9. Who consented to participate by signing and dating the written informed consent form prior to any study-specific procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •1. No baseline measurable lesion (as defined by RECIST 1.1 criteria)
- •2. Constitutive MSI-high patients (status determined on a tissue biopsy obtained before the first-line treatment or at the first-line treatment start)
- •3. Still under first line oncological treatment regimen
- •4. Any contraindication to intra-muscular injection as estimated by the investigator including but not limited to concomitant treatment with an anticoagulant which cannot be temporarily discontinued for allowing safe IN01 injections, as per recommended specific anticoagulant management.
- •5. Any contraindication (absolute or relative) to the monotherapy treatment with the planned concomitant small inhibitor molecule (trametinib for cohort A or encorafenib for cohort B) according to its approved summary of product characteristics
- •6. History of other cancer, unless in complete remission and off all chemotherapy and/or radiotherapy for that disease for a minimum of 5 years
- •7. Use of immunosuppressant drugs such as azathioprine, tacrolimus, cyclosporine, etc. Immunosuppressants are not permitted within 1 month before first IMP administration
- •8. Administration of any other vaccines with the exception of the influenza and COVID-19 vaccines, within 28 days before first IMP administration
- •9. Known history of any autoimmune disease
- •10. Any known primary or secondary immunodeficiencies (e.g. documented Human Immunodeficiency Virus [HIV]) not resolved at least 2 months before IMP administration
- •11. Treatment with oral, intramuscular or intravenous corticosteroids. Use is not permitted within 7 days before first IMP administration. Inhaled corticosteroids to treat respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), or topical steroids are permitted
- •12. History of splenectomy
- •13. Known incompatibility to both CT scan and MRI
- •14. Female patients who are pregnant or lactating
- •15. Any evidence that the patient is unlikely to comply with study treatment, procedures, restrictions or requirements, including uncontrolled systemic or psychiatric diseases (e.g. active infection, uncontrolled hypertension, unstable heart, liver, kidney or metabolic disease) which may compromise the patient’s safety or ability to participate in the study
- •16. Patients who have received any investigational treatment agent within 28 days before first IMP administration
- •17. Known allergies, hypersensitivity, or intolerance to the IMP, its excipients or any other vaccine
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