2024-518529-14-00招募中2 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.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Transgene
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Phase I part: Overall incidence of AEs and DLTs, SAEs
研究概览
简要总结
Phase I Part A: Assess the local and systemic safety and tolerability of BT-001 as a single agent in repeated IT administrations at 10E6 to 10E8 PFU/mL; determine the Maximum Tolerated Dose (MTD). Phase I, Part B: Assess the local and systemic safety and tolerability of BT-001 in repeated IT administrations, at the RDPB, in combination with IV infusions of pembrolizumab Phase II: Evaluate the antitumor activity of BT-001 in repeated IT administrations in combination with IV infusions of pembrolizumab.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Provide signed written informed consent
- •Use a highly effective contraception method combined with a barrier method during and after study treatment
- •Have received complete COVID-19 primary-vaccination at least 30 days before first IMP(s) administration.
- •Have an interval of at least 3 weeks between first IMP(s) administration and exposure to prior chemotherapy
- •Have adequate hematological, hepatic, and renal functions.
- •Be male or female patient aged ≥ 18 years.
- •Have histologically confirmed, advanced/metastatic sarcoma (soft tissue and bone), MCC, melanoma, TNBC, or NSCLC, with cutaneous or, palpable subcutaneous lesions or, easily injectable lymph nodes
- •Have failed and/or are intolerant to standard therapeutic options
- •Have at least 1 injectable cutaneous, subcutaneous or nodal lesion
- •Have an expected survival of at least 3 months
- •Have knowledge of his/her anti-variola vaccine status.
- •Agree to provide a fresh tumor sample of the lesion that will be injected first
- •Have an Eastern Cooperative Oncology Group performance status of 0 or 1
排除标准
- •Have a tumor adjacent to the trachea or a major blood vessel for planned injection.
- •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
- •Is taking an anticoagulant medication that cannot be interrupted prior to IT injections
- •Have had an allogeneic tissue/solid organ transplant or allogeneic stem cell or bone marrow transplantation
- •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
- •Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Has known active CNS metastases and/or carcinomatous meningitis.
- •Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
- •Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- •Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease
- •Has an active infection requiring systemic therapy
- •Have had major surgery within 4 weeks of first IMP(s) administration
- •Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority
- •Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •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, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
- •Has received radiation therapy to the lung that is >30Gy within 6 months of the first dose of trial treatment for patients having NSCLC
- •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
- •Have known hypersensitivity to egg or to any excipients of BT-001
- •Have a history of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina pectoris, uncontrolled infection, or myocardial infarction 6 months prior to clinical trial entry.
- •COVID-19 vaccination or infection within 2 weeks prior to start of treatment
- •History of monkeypox infection or anti-monkeypox vaccination within 30 days prior to the first dose of study intervention
- •Have received prior treatment with a vaccinia oncolytic virus
- •Have received antiviral therapy active on vaccinia virus (VV), e.g., ribavirin, interferon/pegylated interferon
- •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 co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE)
- •Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to the start of treatment
- •Have received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
- •Have received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention
- •A Women Of ChildBearing Potential who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment
结局指标
主要结局
Phase I part: Overall incidence of AEs and DLTs, SAEs
Phase I part: Overall incidence of AEs and DLTs, SAEs
Phase IIa part - Soft Tissue Sarcoma cohort: Progression Free Rate at 6-months according to iRECIST
Phase IIa part - Soft Tissue Sarcoma cohort: Progression Free Rate at 6-months according to iRECIST
Phase IIa part - All cohorts except Soft Tissue Sarcoma : Immune Overall Response Rate according to iRECIST.
Phase IIa part - All cohorts except Soft Tissue Sarcoma : Immune Overall Response Rate according to iRECIST.
次要结局
- Overall incidence of AEs and DLTs, SAEs (Phase IIa part)
- Disease Control rate overall and at 4-month using RECIST 1.1 and iRECIST
- Progression Free Survival using RECIST 1.1 and iRECIST
- Overall Survival
研究者
Julien Romanetto
Scientific
Transgene
研究点 (5)
Loading locations...
相似试验
招募中
1 期
A phase I/IIa clinical study of BT-001 in the treatment of patients withmetastatic or advanced solid cancer.Phase I: Advanced or metastatic solid tumors including Non-Hodgkin Lymphoma (NHL) and preferably Soft Tissue Sarcoma, Merkel Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Non Smal Cell Lung Cancer Phase IIa: Soft Tissue Sarcoma, Merkel Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Non Smal Cell Lung CancerMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2020-000505-80-FRTRANSGENE48
进行中（未招募）
1 期
A phase I/IIa clinical study of BT-001 in the treatment of patients withmetastatic or advanced solid cancer.Phase I: Advanced or metastatic Soft Tissue Sarcoma, Merkel Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Non Smal Cell Lung Cancer Phase IIa: Soft Tissue Sarcoma, Merkel Cell Carcinoma, Melanoma, Triple Negative Breast Cancer, Non Smal Cell Lung CancerMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000505-80-BETRANSGENE258
终止
1 期
A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid TumorsMetastatic CancerSoft Tissue SarcomaTriple Negative Breast CancerNon Small Cell Lung CancerMelanomaMerkel Cell CarcinomaNCT04725331Transgene31
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18
招募中
1 期
Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced CancersNCT07260708Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.42