EUCTR2017-001111-36-AT进行中（未招募）1 期
An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors - CANFOUR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Cantargia AB
- 入组人数
- 116
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.Ability to understand and willingness to provide written informed consent before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
- •2.Age = 18 year.
- •3.Measurable disease in accordance to irRC (subjects enrolled prior to protocol version 7.0) or iRECIST (subjects enrolled after protocol version 7.0) by computed tomography (CT) or magnetic resonance imaging (MRI) scan. Imaging tests performed up to 2 weeks before ICF signature are valid for trial entry if they are performed with the same technique/equipment as the future follow-up tests.
- •4.At least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status =1.
- •6.Adequate bone marrow, hepatic, renal and coagulation function.
- •7.Clinical laboratory values at screening:
- •?Serum creatinine <1.5xULN
- •?Hemoglobin >9.0 g/dL
- •?Absolute neutrophil count >1000/µL in Part I and >1500/µL in Part II
- •?Platelets >75x109/L for CAN04 monotherapy, and 100x109/L for the combination with chemotherapy (Arms C and D).
- •?Total bilirubin <1.5x ULN
- •?Aspartate Transaminase (AST) and Alanine Transaminase (ALT) =3x ULN (for subjects with hepatic metastases < 5x ULN)
- •?Prothrombin Time (PT) & Partial Thromboplastin Time (PTT) within 1.5x institutional ULN. In case there are no normal ranges available for the PT test, the international normalized ratio (INR) test may be used instead of PT. At screening, subjects should have an INR <1.5x ULN.
- •Additional inclusion criterion for Part I:
- •8.Subject with histologically or cytologically confirmed, unresectable, locally advanced or metastatic NSCLC, PDAC, CRC or TNBC tumor, relapsed or refractory to standard therapy or for which there is no standard therapy.
- •Additional inclusion criterion for Part II:
- •9.Arm A, Arm B and Arm E: Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic squamous or non-squamous NSCLC or PDAC, relapsed or refractory to standard of care therapy or for whom there is no standard therapy.
- •10.All arms: Presence of tumor lesions amenable to biopsy and willingness to undergo repeat biopsies of these tumor lesions. It is not necessary to repeat the baseline biopsy procedure if: (i) there is enough archival material available, (ii) it has been preserved adequately, (iii) the subject did not receive any systemic anticancer treatment from the day of biopsy sampling and until the first dose of study drug, and (iv) if the sample is less than 60 days old from the treatment start.
- •11.Arm C only:
- •11a: Subjects with histologically or cytologically confirmed diagnosis of unresectable stage IIIB or stage IV squamous or non-squamous NSCLC.
- •11b: Subjects must be eligible to receive a first line standard chemotherapy regimen with cisplatin/gemcitabine or a second line standard chemotherapy regimen with cisplatin/gemcitabine after relapsing from first line with pembrolizumab monotherapy.
- •11c: Subjects who underwent (neo)adjuvant treatments are eligible if the (neo)adjuvant treatment ended at least 6 months prior to inclusion.
- •12.Arm D only:
- •12a: Subjects with newly diagnosed, treatment na?ve, histologically or cytologically confirmed, unresectable, locally advanced or meta
排除标准
- •1.Known or suspected allergy to trial product or related product.
- •2.Subjects receiving live vaccination, etanercept or other TNF-a inhibitors or any other investigational agents during or just prior to (within 28 days of first study drug administration) participation in this study.
- •3.Previous participation in this trial (enrolled).
- •4.Clinical evidence of an active metastatic second malignancy.
- •5.Subjects with a life expectancy <12 weeks.
- •6.Uncontrolled or significant cardiovascular disease defined as New York Heart Association Classification III, or IV.
- •7.Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- •8.Not recovered from the adverse effects of prior therapy at the time of enrollment to = grade 1, with the exception of alopecia grade 2.
- •9.Symptomatic brain metastases, which are either untreated or uncontrolled by surgery and/or radiotherapy.
- •10.Immunocompromised subject currently receiving systemic therapy.
- •11.Known history of autoimmune disorders, human immunodeficiency virus (HIV) infection, or any other relevant congenital or acquired immunodeficiency. Known hepatitis B (HBV) surface antigen seropositive or detectable hepatitis C (HCV) infection viral load. Note: Patients who have positive hepatitis B core antibody or hepatitis B surface antibody can be enrolled but must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody must have an undetectable hepatitis C viral load.
- •12.Known bleeding disorder or coagulopathy.
- •13.Subjects with microbial or viral infection, which is not controlled by appropriate medication. Subjects with any type of chronic infection.
- •14.Women who are pregnant or breastfeeding.
- •15.Women of childbearing potential (WOCBP, defined as < 2 years after last menstruation and not surgically sterile) or men whose sexual partners are WOCBP who are unwilling or unable to use a highly effective method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3-6 months after the last dose of study medication, depending on the treatment arm. Also see section 6.1.10.1 – Contraception Methods.
- •16.Evidence of serious uncontrolled medical disorder or active infection that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol.
- •17.Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion.
- •18.Only for Arm C:
- •18a Prior lines of treatment with anti-cancer medication other than pembrolizumab monotherapy administered as 1st line.
- •18b Known tumor EGFR mutation, unless contraindication to EGFR-directed therapy.
- •18c Known tumor ALK rearrangements, unless contraindication to ALK-directed therapy or ALK-directed therapy not available.
研究者
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