A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.
研究概览
简要总结
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour.
GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start the immune response in the body to have effect of GV-1001.
LTX-315, also a peptide, in development for cancer treatment. In this study, the investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating the immune system.
详细描述
This clinical study has two main aims which are:
- To measure the immunological effects of LTX-315 in combination with GV1001
- Find out about the side effects of the combination of the two drugs This is an open label, single centre study assessing immunological effects and safety of LTX-315 given as an adjunct to GV1001. The LTX-315 dose will escalate while the GV1001 dose will be fixed.
LTX-315 and GV1001 will be given as intradermal injections on days 1, 8, 15, 22 and 36.
Investigational treatment: LTX-315 (0.10 mL) with escalating concentrations will be injected intradermally, followed, 1-2 hours later, by intradermal injection of 0.56 mg GV1001 (0.20 mL, 2.8 mg/mL) in the same site, in one arm.
DTH-test control: 0.10 mg GV1001 (0.10 mL) will be injected intradermally in the contralateral arm without LTX-315, as a DTH skin reactivity test control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Curative surgery for carcinoma performed at least three months prior to treatment start
- •Age ≥18 years
- •ECOG Performance status (PS): 0
- •Life expectancy: at least 3 months
- •Laboratory requirements:
- •White Blood Count (WBC) ≥ 3 x 109/L
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •Platelet count ≥ 100 x 109/L
- •Haemoglobin ≥ 10.0 g/dL
- •Total bilirubin level ≤ 1.5 ULN
- •AST and ALT ≤ 2.5 x ULN
- •Creatinine ≥ 1.5 ULN
- •Albumin > 30 g/L
- •No expectation of anti-cancer therapy or immunotherapy during the trial period, hormone therapy given as adjunctive or contraceptive therapy is permitted
- •Must be willing to practice acceptable barrier methods of birth control to prevent pregnancy
- •The patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination
- •The patient has been fully informed about the study and has signed the informed consent form
排除标准
- •Has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period
- •Has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents
- •Has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (< Grade 1) due to agents administered more than 4 weeks earlier
- •Has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events
- •Is currently on any agent with a known effect on the immune system
- •Has any other serious illness or medical condition such as but not limited to:
- •Any uncontrolled infection or infection requiring antibiotics
- •Uncontrolled cardiac failure Classification III or IV (New York Heart Association)
- •Uncontrolled systemic and gastro-intestinal inflammatory conditions
- •Bone marrow dysplasia
- •History of auto-immune disease
- •History of adverse reaction to vaccines
- •Known history of positive tests for HIV/AIDS, hepatitis B or C
- •Is pregnant or breastfeeding
研究组 & 干预措施
LTX-315
The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001.
干预措施: LTX-315 (Drug)
结局指标
主要结局
Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.
时间窗: 5 injections, treatment period 36 days
Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.
次要结局
- To evaluate the safety profile of LTX-315 in combination with GV1001 study(5 injections, treatment period 36 days)