2024-518529-14-00
招募中
1/2 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.
概览
- 阶段
- 1/2 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
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
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
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)
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