EUCTR2020-000505-80-BE进行中（未招募）1 期
A phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone and in combination with pembrolizumab in patients with cutaneous or, subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- TRANSGENE
- 入组人数
- 258
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
- •Phase I part B and Phase IIa
- •I1 Signed informed consent in accordance to ICH-GCP and national/local regulation before starting any protocol-related procedures
- •I2 Male or female patient aged = 18 years
- •I3 Histologically confirmed, advanced/metastatic sarcoma (soft tissue and bone), MCC, melanoma, Triple TNBC, or NSCLC, with cutaneous or, palpable subcutaneous lesions or, easily injectable lymph nodes
- •I4 Failed and/or are intolerant to standard therapeutic options
- •I5 At least 1 injectable cutaneous, subcutaneous or nodal lesion measurable according to RECIST 1.1 and not exceeding 50mm in the longest diameter and whenever possible another non-injected measurable lesion
- •I6 Expected survival of at least 3 months.
- •I7 Knowledge of his/her anti-variola vaccine status
- •I8 Agree to provide a fresh tumor sample of the lesion
- •I9 ECOG status of 0 or 1
- •I10 Highly effective contraception method combined with a barrier method during and after study treatment
- •I11 Complete COVID-19 primary-vaccination
- •I12 Interval of at least 3 weeks between first IMP(s) administration and exposure to prior chemotherapy, 4 weeks for immunotherapy and antibody-based therapy, and 2 weeks for palliative radiotherapy
- •I13 Have adequate hematological, hepatic and renal functions:
- •Hemoglobin = 9 g/dL (without packed red blood cell transfusion
- •within the prior 2 weeks)
- •Neutrophils = 1.5 x10E9/L
- •Lymphocytes = 0.750 x 10E9/L
- •Platelets =100 x10E9/L
- •ALT and AST = 2.5 x ULN; total bilirubin is = 1.5 x ULN
- •Total bilirubin = 1.5 x ULN, except for patients with Gilbert syndrome who must have a total bilirubin level < 3.0 x ULN
- •Lactate dehydrogenase = 3 x ULN
- •Creatinine clearance = 60 mL/min according to the Cockroft & Gault formula
- •International normalized ratio (INR) = 1.5 x ULN
- •Additional criteria applicable according to patient's condition:
- •IC- Soft Tissue Sarcoma (STS) Cohort:
- •IC-1 Have a histologically confirmed metastatic and/or locally advanced inoperable undifferentiated pleomorphic sarcoma/myxofibrosarcoma, cutaneous angiosarcoma, dedifferentiated liposarcoma or leiomyosarcoma.
- •IC-2 Have at least 1 injectable cutaneous or, palpable subcutaneous soft tissue or nodal lesion.
- •IC-3 Have failed and/or are intolerant to standard therapeutic options.
- •ID- Merkel Cell Carcinoma (MCC):
- •ID-1 Have histologically confirmed unresectable stage III or metastatic MCC.
- •ID-2 Have failed and/or are intolerant to standard therapeutic options.
- •IE- Melanoma:
- •IE-1 Have pathologically confirmed metastatic or unresectable stage IIIb/c of IV melanoma with at least one cutaneous or, subcutaneous tumor or palpable lymph node amenable to IT injection.
- •IE-2 Have failed and/or are intolerant to prior treatment with anti-PD-1 or anti-PD-L1 agents alone or in combination with anti-CTLA-4.
- •IE-3 Have received therapy targeting BRAF or MEK when appropriate and have failed and/or are intolerant to it
- •IE-4 Do not have disease that is suitable for local therapy with curative intent
- •IE-5 Have not received previous treatment with Imlygic
- •IF- Triple Negative Breast Cancer (TNBC):
- •IF-1 Have metastatic or locally advanced, histologically confirmed TNBC characterized by absence of human epidermal growth factor 2, estrogen receptor, and progesterone receptor expression.
- •IF-2 Have failed and/or are intolerant to standard therapeutic options.
- •IF-3 Have documented disease progression on or after the most recent therapy.
- •IG- Non-Small Cell Lung Cancer (NSCLC):
- •IG-1. Have histologically confirmed NSCLC, stage IIIb-IV or delayed
排除标准
- •Phase I Part B and Phase IIa:
- •E1 Have a tumor adjacent to the trachea or a major blood vessel for planned injection.
- •E2 Have had major surgery within 4 weeks of first IMP(s) Phase I Part B and Phase IIa:
- •E1 Have a tumor adjacent to the trachea or a major blood vessel for planned injection.
- •E2 Have had major surgery within 4 weeks of first IMP(s) administration.
- •E3 Have received prior treatment with a vaccinia oncolytic virus.
- •E4 Have received antiviral therapy active on vaccinia virus (VV), e.g., ribavirin, interferon/pegylated interferon..
- •E5 Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immunerelated
- •Adverse Event (irAE).
- •E6 Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the start of treatment.
- •E7 Have received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.
- •E8 Have received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- •E9 A WOCBP who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment.
- •E10 Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- •E11 Is taking an anticoagulant medication that cannot be interrupted prior to IT injections.
- •E12 Have had an allogenic tissue/solid organ transplant or allogenic stem cell or bone marrow transplantation.
- •E13 Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 28 days prior the first dose of study drugs.
- •E14 Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •E15 Has known active CNS metastases and/or carcinomatous meningitis.
- •E16 Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
- •E17 Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •E18 Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
- •E19 Has an active infection requiring systemic therapy.
- •E20 Has a known history of HIV infection.
- •E21 Has a known history of Hepatitis B or known active Hepatitis C virus infection.
- •E22 Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study
- •E23 Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
- •E24 Has received radiation therapy to the lung that is >30Gy within 6 months of the first dose of trial treatment for patients having NSCLC
- •E25 Have a history of severe exfoliative skin conditions (e.g., eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to BT-001 initiation
- •E26 Have known hypersensitivity to egg or to any excipients of BT-001
- •E27 Have a history of myocarditis or congestive heart failure, unstable
- •angina pectoris, uncontroll
研究者
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