NCT05788926终止1 期
A Phase I Dose-escalation Trial of TG6050 Administered by Intravenous Infusion in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Transgene
- 入组人数
- 22
- 试验地点
- 5
- 主要终点
- Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)
研究概览
简要总结
This is a phase I, open-label, dose-escalation trial of TG6050 administered by single or repeated IV infusion(s).
详细描述
This clinical trial aims at determining the dose and schedule of administration of TG6050 for further development, primarly based on the assessment of the safety and tolerability of single and repeated IV infusions at escalating doses in patients with advanced NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent in accordance with International Conference on Harmonization-Good Clinical Practice and national/local regulations
- •Male or female patient aged 18 to 75 years
- •Histologically confirmed metastatic (stage IV) NSCLC
- •No known oncogenic driver alteration with available targeted therapy, including EGFR, HER2, KRASG12C, MET or BRAFV600E gene mutations and ALK, ROS1, or RET gene fusion/rearrangements. Patients with KRASG12C mutation having received a targeted therapy will be eligible
- •Have received all standard therapeutic options available, including at least 4 months of treatment with an anti-PD1 or PD-L1 monoclonal antibody and doublet platinum-containing chemotherapy
- •Have documented progression not earlier than 4 months after initiation of the anti-PD(L)1 therapy
- •Have at least one measurable lesion according to RECIST 1.1 and at least one lesion amenable to biopsy
- •Expected life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Time from prior immunotherapy or antibody-based therapy to first TG6050 administration of at least 4 weeks, from prior chemotherapy of at least 3 weeks, and from palliative radiotherapy of at least 2 weeks
- •Adequate hematological, hepatic, and renal functions
- •Clearance for trial participation after cardiology consultation and cardiologic investigations
- •Negative pregnancy test in women of childbearing potential (WOCBP)
- •Commitment to use a highly effective contraception method (i.e., with a failure rate of ≤1 % per year) combined with a barrier method (e.g., condom) during TG6050 administration period and at least 3 months after TG6050 administration, in men and WOCBP
排除标准
- •Major surgery within 4 weeks of first TG6050 administration
- •Prior treatment with ipilimumab
- •Prior treatment with an oncolytic virus
- •Prior treatment with another investigational agent within 4 weeks of first TG6050 administration
- •Immunodeficiency due to underlying illness and/or immune-suppressive medication
- •Uncontrolled intercurrent illness
- •Active auto-immune disease except hypothyroidism or type I diabetes only requiring hormone replacement therapy
- •Brain metastases, unless treated and stable for at least 4 weeks after medical imaging assessment
- •Other malignancies than NSCLC except cutaneous basal cell carcinoma and in situ carcinoma of the uterine cervix, unless complete remission for at least 5 years prior to trial entry and no therapy required during the trial
- •Ongoing antiviral therapy active on vaccinia virus (VV), e.g., ribavirin, interferon/pegylated interferon
- •History of monkeypox infection or anti-monkeypox vaccination
- •History of severe exfoliative skin conditions
- •History of grade ≥ 3 auto-immune manifestations related to ICI therapy
- •History of severe systemic reaction or side-effect after a smallpox vaccination
- •History of solid organ or allogeneic stem cell transplantation
- •Known hypersensitivity to eggs or any TG6050 excipients
- •Positive test for hepatitis C virus (HCV) or hepatitis B virus (HBV) indicating acute or chronic infection
- •Live virus vaccination within 28 days of TG6050 administration
- •COVID-19 vaccination or infection within 14 days of TG6050 administration
- •Breastfeeding woman
- •Any medical, familial, sociological, or psychiatric condition that in the opinion of the investigator would prohibit inclusion in the trial
研究组 & 干预措施
Dose escalation of TG6050
Experimental
Dose escalation with single or repeated administrations of TG6050 by intravenous route in patients with advanced NSCLC.
干预措施: TG6050 (Drug)
结局指标
主要结局
Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)
时间窗: Up to 5 years
Incidence of Adverse Event reported per NCI-CTCAE v5.0, Dose limiting toxicity, Maximal tolerated dose, Maximum feasible dose and Serious Adverse Events.
次要结局
- Molecular responses (MR)(Up to 1 year)
- Overall response rate (ORR)(Up to 1 year)
- 4-month disease control rate(Up to 4 months)
- Overall disease control rate (DCR)(Up to 1 year)
- Progression-free survival (PFS)(Up to 1 year)
- Overall survival (OS)(Up to 1 year)
- Duration of overall response (DoR)(Up to 1 year)
研究者
研究点 (5)
Loading locations...
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