EUCTR2020-000505-80-FR招募中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
- 招募中
- 发起方
- TRANSGENE
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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. At least 1 injectable measurable cutaneous, subcutaneous or nodal lesion greater or equal to 2 cm in longest diameter; or multiple injectable lesions (maximum 5) that in aggregate have a longest diameter of at least 2 cm, and whenever possible 1 distant non-injected measurable lesion
- •I4. Expected survival of at least 3 months
- •I5. Knowledge of his/her anti-variola vaccine status
- •I6. Provide a fresh tumor sample at baseline and be willing to supply new tumor samples from a biopsy during treatment.
- •I7. ECOG performance status of 0 or 1
- •I8. Interval of at least 3 weeks between first study drug injection and exposure to prior chemotherapy; 4 weeks for immunotherapy and antibody-based therapy and 2 weeks for palliative radiotherapy
- •I9. Adequate hematological, hepatic and renal functions:
- • Haemoglobin = 9 g/dL
- • Neutrophils = 1 x10E+9/L
- • Lymphocytes = 0.750 x 10E+9/L
- •Platelets = 100 x10E+9/L
- • Alanine aminotransferase (ALT) and aspartate aminotransferase [AST]) = 3 x ULN (up to 5 x ULN if patients exhibits liver metastases); total bilirubin = 1.5 x ULN except for patients with Gilbert’s syndrome who may be included if total bilirubin = 2.5 x ULN
- • Serum creatinine = 1.5 x ULN or creatinine clearance = 60 mL/min according to Cockroft & Gault formula
- • International normalized ratio (INR) = 1.5
- •I10.Appropriate precaution against pregnancy whilst on study:
- •- Women of childbearing potential (WOCBP) potential must have a negative pregnancy test prior to study entry.
- •- Both men and WOCBP must be using a highly effective contraception method combined with a barrier method (e.g. condom) during BT-001 treatment period and for a minimum of 4 months following the last administration of BT-001
- •For patients included in Phase I (parts A and B):
- •IA-1Have histologically confirmed, advanced/metastatic solid tumors including non-Hodgkin lymphoma (NHL) and preferably sarcoma (soft tissue and bone), MCC, melanoma, TNBC or NSCLC, with cutaneous or, palpable subcutaneous lesions or easily injectable lymph nodes
- •For patients included in Phase I, Part A (single agent) only:
- •IB-1 Patients who have failed and/or are intolerant to standard therapeutic options.
- •For patient included in Phase IIa:
- •IC- Soft Tissue Sarcoma (STS) Cohort:
- •IC-1Have a histologically confirmed metastatic and/or locally advanced inoperable undifferentiated pleomorphic sarcoma/myxofibrosarcoma, cutaneous angiosarcoma, dedifferentiated liposarcoma or leiomyosarcoma.
- •IC-2Have at least 1 injectable cutaneous or, palpable subcutaneous soft tissue or nodal lesion = 20 mm in longest diameter.
- •IC-3Have at least one prior line of systemic therapy. A naive patient may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count if it was completed more than 6 months previously.
- •ID- Merkel Cell Carcinoma (MCC):
- •ID-1Have histologically confirmed stage IV MCC.
- •ID-2Have received at least 1 line of treatment for metastatic MCC and have progressed after the most recent line of treatment.
- •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 had prior treatment with anti-PD-1 or anti-PD-L1 agents
排除标准
- •E1 Have a tumor adjacent to the trachea or a major blood vessel.
- •E2 Have had major surgery within 4 weeks of first study drug administration.
- •E3 Have received prior treatment with a vaccinia oncolytic virus.
- •E4 Have known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including systemic corticosteroids.
- •E5 Have received antiviral therapy active on vaccinia virus (VV), e.g., ribavirin, interferon/pegylated interferon.
- •E6 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.
- •E7 Have uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social circumstances that could limit compliance with study requirements.
- •E8 Have had a Grade = 3 auto-immune manifestations of previous ICIs (e.g., anti-PD-1, anti-PDL1, anti-CTLA-4, or another immune checkpoint targeting agent under investigation).
- •E9 Have received treatment with another investigational agent within 21 days before the inclusion.
- •E10 Taken an anticoagulant medication that cannot be interrupted prior to IT injections.
- •E11 Have active brain metastasis (stable and treated metastasis are accepted).
- •E12 Have had any organ transplantation, including allogenic stem cell or bone marrow transplantation.
- •E13 Have known hypersensitivity to egg.
- •E14 Have had any positive test for hepatitis C virus (HCV) or hepatitis B virus (HBV) indicating acute or chronic infection.
- •E15 Are pregnant or a breastfeeding woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL).
- •E16Have any medical, familial, sociological or psychiatric condition that in the opinion of the investigator would prohibit inclusion in the trial.
- •For patients included in Phase I, Part B and IIa only:
- •EA-1. Patient with an active known or suspected auto-immune disease. Patient with type I diabetes or hypothyroidism only requiring hormone replacement are permitted to enroll.
- •EA-2. Have interstitial lung disease that is symptomatic and may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- •EA-3. Have known hypersensitivity to the active substance or to any of the excipients of pembrolizumab.
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