NCT03839524已完成1 期
A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Transgene
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
研究概览
简要总结
This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Female patients ≥ 18 years
- •Histologically confirmed high grade, advanced stage serous ovarian, fallopian tube or primary peritoneal carcinoma.
- •Patients who have undergone primary debulking surgery or interval debulking surgery and have completed standard first-line platinum-based chemotherapy and for whom tumor tissue has been banked.
- •Patients must have achieved a complete response to therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation
- •Adequate hematological, hepatic and renal functions.
排除标准
- •Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-Programmed cell death 1 (anti-PD1), anti-Programmed death-ligand 1 (anti-PDL1) or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTL4)
- •Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma.
- •Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation.
- •Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
- •Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
- •Acute or chronic infection with hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).
- •Major surgery within 4 weeks of treatment start.
- •Treatment with another investigation agent within 30 days prior to TG4050 treatment initiation.
- •Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs . Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
- •Use of live vaccine for the prevention of infectious diseases during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration.
- •Uncontrolled intercurrent illness.
研究组 & 干预措施
TG4050 arm
Experimental
Patients in this arm will receive injections of TG4050 Investigational Medicinal Product.
干预措施: TG4050 (Drug)
结局指标
主要结局
Safety and Tolerability (Adverse Event Reported Per CTCAE v5)
时间窗: Up to 1 year . Adverse events were collected from treatment initiation weekly for the first six weeks, every three weeks thereafter until 30 days after the last treatment administration.
Incidence of Adverse Events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
次要结局
- Failure to Provide Rate(From informed consent (ICF) signature up to baseline.)
- CA-125 Response According to GCIC(Up to 1 year. CA-125 response assessment every 3 weeks from the start of study treatment until treatment discontinuation.)
- Tumor Response According to RECIST 1.1(Starting on Day 43 and then every nine weeks thereafter, until disease progression (estimated 12 months).)
- Time to Measurable Relapse/Progression Per RECIST 1.1(43 days after treatment, and thereafter every 9 weeks until disease progression or relapse (estimated 12 months).)
研究者
研究点 (6)
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