EUCTR2017-002243-15-GB进行中（未招募）1 期
A Phase I/II Open-Label, Multi-center Study of the Safety and Efficacy of IMCnyeso, an HLA-A* 0201-Restricted, NY-ESO-1 and LAGE-1A-specific soluble T Cell Receptor and Anti-CD3 Bi-specific Molecule, as a Single Agent in HLA-A* 0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE-1A Positive Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
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
- •Patients must meet all the following inclusion criteria to be eligible for
- •inclusion in the study:
- •1.Male or female patients age = 18 years of age at the time of informed
- •2.Ability to understand and provide written informed consent prior to
- •undergoing any studyprocedures
- •3.Life expectancy of > 3 months as estimated by the Investigator
- •4.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
- •or 1 at Screening
- •5.In the opinion of the Investigator, all other relevant medical conditions
- •must bewell-managed and stable for at least 28 days prior to first
- •administration of study drug HLA and Tumor Antigen Testing
- •6.HLA-A*02:01 positive as confirmed by the central laboratory
- •7.NY-ESO-1 and/or LAGE-1A positive tumor confirmed by the central
- •Phase I: Disease Under Study and Prior Anti-Cancer Treatment
- •8.Histologically confirmed diagnosis of advanced NSCLC, melanoma,
- •urothelial carcinoma,or synovial sarcoma
- •9.Patients must be relapsed from, refractory to, or intolerant to all
- •approved and availableclasses of therapy known to provide clinical
- •benefit for their condition
- •Phase II: Disease Under Study and Prior Anti-Cancer Treatment
- •10.Histologically confirmed diagnosis of advanced NSCLC, urothelial
- •carcinoma, or synovialsarcoma
- •11.Measurable disease per Response Evaluation Criteria in Solid Tumors
- •(RECIST) v.1.1criteria (Section 13.1)
- •12.A minimum of 10 patients enrolled in Phase II must have disease that
- •is amenable tobiopsy, and consent to provide biopsies during Screening
- •and on treatment
- •13.Patients will have received the following previous therapies. These
- •therapies must havebeen given for unresectable / metastatic disease or
- •given in the adjuvant setting if diseaseprogression occurred during or
- •within 6 months of completing adjuvant therapy
- •NSCLC — PD-1/PD-L1 inhibitor. Patients with a genomic tumor
- •aberration (eg, EGFR,ALK) that is targeted by Health Authority-approved
- •agent(s) must be relapsed from,refractory to, or intolerant of relevant
- •targeted agent(s)
- •Urothelial cancer — PD-1/PD-L1 inhibitor
- •Synovial sarcoma — at least 1 prior systemic chemotherapy regimen
- •Contraception
- •14.Female patients should either be of non-childbearing potential or
- •must agree to use highly effective methods of contraception from
- •Screening until 6 months following administration of the last dose of
- •study drug (see Section 6.14)
- •15.Male patients must be surgically sterile or use double barrier
- •contraception from enrollment through treatment and for 6 months
- •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 53
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients with any of the following will not be included in the study:
- •Disease Under Study and Prior Anti-Cancer Treatment
- •-Presence of symptomatic or untreated CNS metastases, leptomeningeal disease, cord compression, or CNS
- •metastases that require doses of corticosteroids within 3 weeks prior to the planned first administration of study drug.
- •-Systemic anticancer therapy for disease under study within 2 weeks of the planned first administration of study treatment. For
- •cytotoxic or immunotherapy agents that can present with major delayed toxicity, a 4-week washout period is required
- •-Radiotherapy within 2 weeks of the planned first administration of
- •study drug.
- •-Presence of National Cancer Institute Common Terminology Criteria for AEs = Grade 2 toxicity due to prior cancer therapy (except Grade 2 alopecia, stable Grade 2 peripheral neuropathy, Grade 2 endocrine disorder [on stable replacement doses and without
- •symptoms]Grade 2 hypophosphatemia [on appropriate replacement therapy] and Grade 2 ototoxicity) Laboratory Parameters
- •-Patient with any out-of-range laboratory values defined as shown below. Hematology evaluations must be performed = 7 days after any
- •blood or blood product transfusion and= 14 days after any dose of
- •hematologic growth factor.
- •Creatinine clearance (calculated using Cockcroft-Gault formula or
- •measured)< 40 mL/min
- •Total bilirubin > 1.5 × upper limit of normal (ULN); NOTE: for patients
- •with Gilbert's syndrome; exclude if total bilirubin > 3.0 × ULN or direct
- •bilirubin > 1.5 × ULN)
- •Alanine aminotransferase (ALT) > 3 × ULN
- •Aspartate aminotransferase (AST) > 3 × ULN
- •Absolute neutrophil count (ANC) < 1.0 × 109/L
- •Absolute lymphocyte count < 0.5 × 109/L
- •Platelet count < 75 × 109/L
- •Hemoglobin < 8 g/dL
- •Medical History and Concomitant Medications
- •-Any active manifestations of autoimmune disease of the skin, including
- •psoriasis and scleroderma, or history of severe skin manifestation of
- •graft versus host disease
- •-Clinically significant cardiac disease or impaired cardiac function
- •including any of the following:
- •-Clinically significant and/or uncontrolled heart disease such as
- •diagnosed congestive heart failure, uncontrolled hypertension, or clinically significant arrhythmia currently
- •requiring medical treatment
- •-Confirmed manually over-read QT interval corrected by Fredericia's method (QTcF)>470 msec on Screening ECG or
- •known history of congenital long QT syndrome
- •-History of acute myocardial infarction or unstable angina pectoris < 6 months prior to planned first administration of study drug
- •-Active infection requiring systemic antibiotic therapy. NOTE: Patients requiring systemic antibiotics for infection must have completed treatment with any IV antibiotics at least 14 days before the planned first administration of study drug and any oral antibiotics at least 7 days before the planned first administration of study drug
- •-Known history of HIV, Testing for HIV status is not necessary unless clinically indicated
- •-Active HBV or HCV infection as defined per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically
- •indicated or the patient has a history of HBV or HCV infection
- •-Patients receiving systemic treatment with steroid therapy (ie, prednisone > 10mg daily[QD] or the equivalent) or any other immunosuppressive
- •medication at any dose level that could interfere with the action of the study drugs, in the opinion of the PI
- •-Treatment for well controll
研究者
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