EUCTR2019-003847-31-GB进行中（未招募）1 期
A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study) - EVICTION Study
ImCheck Therapeutics, Inc.0 个研究点目标入组 197 人开始时间: 2020年5月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 197
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
- •The following criteria must be checked over the screening period and at baseline. ALL inclusion criteria must be met to include the subject in the study:
- •1) Male or female aged =18 years
- •2) Voluntarily signed written informed consent before performance of any study-related screening procedures
- •3) Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer including:
- •a. Group A: bladder, breast, colorectal, gastric, melanoma, ovarian, prostate and PDAC
- •b. Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma
- •c. Group C: melanoma, cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved package labeling of the ICI)
- •4) Willingness to undergo baseline and on-study tumor biopsies
- •5) Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •6) Life expectancy > 3 months as assessed by the Investigator
- •7)Clinical labs:
- •a. Hematology:
- •- Hemoglobin =8.5 g/dL (equal to 5.28 mmol/L; transfusion dependent or independent);
- •- Group A/C only:
- •platelet count =75 × 109/L;
- •lymphocyte count =0.5 × 109/L;
- •absolute neutrophil count =1.0 × 109/L;
- •b. Liver enzymes:
- •- aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 × upper limit of normal (ULN) (<5 × ULN in the case of liver metastases);
- •- bilirubin =1.5 × ULN (<2 × ULN in case of liver metastases);
- •c. Renal function: serum creatinine <1.5 × ULN or creatinine clearance = 50 mL/min (Cockcroft and Gault) for serum creatinine =1.5x ULN.
- •8) 8) Contraceptives measures:
- •a.Women of childbearing potential must:
- •i.have a negative pregnancy test within 1 week before first dose of study drug
- •ii.use highly effective method(s) of birth control consistently and correctly during the study and for at least 5 months after the last dose of study drug
- •iii.agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 5 months after the last dose of study
- •iv.agree to no plan to breastfeed and no plan to become pregnant during the study and for at least 5 months after the last dose of study drug.
- •b.Males who are sexually active must:
- •i.agree to use a condom with spermicidal foam/gel/film/cream/suppository during the study and for at least 5 months after the last dose of study drug
- •ii.agree to not donate sperm during the study and for at least 5 months after the last dose of study drug
- •iii.no plan to father a child during the study or within 5 months after the last dose of study drug.
- •9) Women must not be breastfeeding
- •10) At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts
- •11) Patients must have no available standard of care for their disease, as determined by the treating Investigator
- •12) Patients in the ICT01 Combination arms must meet the eligibility criteria in the approved package labeling of the ICI and meet the following conditions:
- •a. Must not be first-line patients (i.e., must meet Inclusion Criteria #11)
- •b. Must not have any history or ongoing interstitial lung disease
- •c. Must not have undergone prior anterior organ transplantation, including allograft stem cell transplantation
- •13) Indication specific criteria will be provided in the protocol amendment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age ra
排除标准
- •The following criteria must be checked over the screening period and at baseline. If ANY exclusion criterion applies, the subject must not be included in the study:
- •1) Any malignancy of ?9d2 T cell origin
- •2) Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment (does not apply to patients receiving ICI for the combination arms)
- •3) Treatment with investigational drugs within 28 days before study treatment
- •4) Systemic steroids at a daily dose of > 10 mg of prednisone, > 2 mg of dexamethasone or equivalent, for the last 28 days and ongoing
- •5) Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement
- •6) Ongoing immune-related adverse events (irAEs) and/or AEs =grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
- •7) Within 4 weeks of major surgery
- •8) Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
- •9) Primary or secondary immune deficiency
- •10) Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment
- •11) Known/suspected hypersensitivity against ICT01, human or humanized IgGs, PD-1/PD-L1 blockers or their ingredients
- •12) Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •13) Clinically significant cardiac disease including heart failure (New York Heart Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year before study entry
- •14) Dementia or altered mental status that would prohibit informed consent
- •15) Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator
- •16) Active drug or alcohol abuse as assessed by the Investigator
- •17) Patients with uncontrolled and symptomatic brain metastases. Patient with asymptomatic brain metastases are allowed provided they are stable and off therapeutic steroids for at least 4 weeks.
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