EUCTR2019-003847-31-DE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)
ImCheck Therapeutics, Inc.0 个研究点目标入组 409 人开始时间: 2020年1月2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
- 409
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:
- •Part1 and Part2:
- •1) Male or female aged =18 years
- •2) Voluntarily signed written informed consent
- •3) Patients with histologically or cytologically confirmed diagnosis of
- •advanced cancer including:
- •a.Group A: Relapsed/refractory advanced bladder, breast, colorectal,
- •gastric, melanoma, ovarian, prostate and PDAC
- •b.Group B: Relapsed/refractory advanced hematologic malignancies
- •including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse
- •large B cell lymphoma and follicular lymphoma
- •c.Group C: Relapsed/refractory advanced melanoma, bladder, head and
- •neck SCC, and non small cell lung cancer (approved indications in the US
- •& EU for pembrolizumab)
- •d.Group D: persistent or recurrent advanced epithelial ovarian cancer,
- •primary fallopian or primary peritoneal cancer;
- •e.Group E: mCRPC patients who failed prior androgen deprivation
- •therapy. Patients may have also failed prior taxane therapy.
- •f.Group F: Newly diagnosed AML, by WHO 2022 criteria, in patients who
- •are indicated to start treatment with VEN/AZA
- •g.Group G: metastatic or unresectable melanoma with primary
- •resistance following at least 6 weeks of prior CPI treatment for advanced
- •disease, defined as best response of progressive disease or SD of short
- •duration (lasting less than 6 months),
- •h.Group H: locally advanced or metastatic urothelial carcinoma who are
- •not eligible for any platinum-containing chemotherapy, or who have
- •disease progression during or following platinum-containing
- •chemotherapy or within 12 months of neoadjuvant or adjuvant
- •treatment with platinum-containing chemotherapy.
- •i. Group I: metastatic or unresectable, recurrent HNSCC in patients who
- •failed first-line immunotherapy or for whom immunotherapy was
- •contraindicated, or in patients who failed 2 prior systemic regimens
- •including an immunotherapy.
- •4) Willingness to undergo Screening, baseline, and on-study tumor
- •biopsies or BMAs, as applicable;
- •5) ECOG performance status = 1 (expect for Group F)
- •6) Life expectancy > 3 months
- •7)Clinical labs:
- •a. Hematology:
- •- Hemoglobin =8.5 g/dL
- •- All Groups except Group B and F:
- •platelet count =75 × 109/L;
- •lymphocyte count =0.5 × 109/L;
- •absolute neutrophil count =1.0 × 109/L;
- •b. Liver enzymes:
- •- AST and 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
- 另有 16 项未显示
排除标准
- •The following criteria must be checked during 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 pembrolizumab for the combination
- •3) Treatment with investigational drugs within 28 days before study
- •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 lifethreatening
- •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
- •from previous therapies except vitiligo, stable neuropathy up to grade 2,
- •hair loss, and stable endocrinopathies with substitutive hormone
- •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), Patients positive for HIV can be
- •eligible if cluster of differentiation (CD)4+ T-cell counts =350 cells and
- •have no history of AIDS-defining opportunistic infections in the past 12
- •months, as deemed appropriate by the Investigator;
- •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
- •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.
- •Group F Specific Exclusion Criteria all above apply align with VIALE-A
- •trial (DiNardo et al. 2020)
- •18)Patients with t(15;17), t(8;21), inv(16), or t(16;16) karyotypic
- •abnormality.
- •19)Participant has history of myeloproliferative neoplasm (MPN)
- 另有 9 项未显示
研究者
相似试验
进行中（未招募）
1 期
First-in-human study of ICT01 in patients with advanced-stage, relapsed/refractory cancerRelapsed/refractory solid tumors or hematological cancersMedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864EUCTR2019-003847-31-GBImCheck Therapeutics, Inc.197
招募中
1 期
A first-in-human study evaluating the safety of AXA-042 as a single agent in patients with advanced solid tumorsAdvanced solid tumorsCancer - Any cancerACTRN12622000993796Axelia Oncology Pty Ltd18
进行中（未招募）
1 期
A study of PRS-344/S095012 (PD-L1x4-1BB bispecific antibody) in patients with solid tumorsAdvanced and/or metastatic solid tumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2019-003456-36-BEInstitut de Recherches Internationales Servier277
进行中（未招募）
1 期
A study of PRS-344/S095012 (PD-L1x4-1BB bispecific antibody) in patients with solid tumorsEUCTR2019-003456-36-ESInstitut de Recherches Internationales Servier161
进行中（未招募）
1 期
A study of PRS-344/S095012 (PD-L1x4-1BB bispecific antibody) in patients with solid tumorsSoild TumorsMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104CTIS2023-510046-25-00Institut De Recherches Internationales Servier IRIS277