A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients With Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (Safety and Tolerability)
研究概览
简要总结
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
详细描述
The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase 1a and Phase 1b. Phase 1a has 3 stages, Single administration stage, Multiple administration stage and Visceral stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.
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
- •All of the following conditions should be met at screening:
- •Male or female patients 18-75
- •Patients with malignant solid tumors that have been diagnosed by pathology and/or cytology
- •Patients who have progressed on or who cannot tolerate available therapies or for whom curative therapy does not exist
- •Patients with at least one non-injected measurable tumor lesion per RECIST v1.1
- •Patients with lesions suitable for intratumoral injection (the lesion length is at least 10 mm and not exceeding 80 mm)
- •Patients enrolled in the single and multiple administration stages of Phase 1a must agree to provide pre- and post-treatment tumor biopsy tissues
- •Patients must have adequate organ and marrow functions
- •Patients with treated brain metastases are eligible if meeting protocol's requirement
- •Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin C), hormonal, biological, targeted agents, other investigational therapy or radiotherapy
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Patients who have received prior IL-12 either alone or as part of a treatment regimen
- •Patients who have received prior therapy with an immuno-oncology agent and were discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
- •Patients requiring therapeutic doses of anticoagulation
- •Patients with tumors that impinge on major airways, blood vessels, or nerve bundles
- •Patients with a history of autoimmune disease that has the possibility of recurrence or active autoimmune disease that requires immunosuppressive medications
- •Patients who had a major surgical procedure within 4 weeks prior to the first dose of study treatment
- •Current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of study treatment
- •Patient with history of solid organ or allogenic bone marrow transplantation
研究组 & 干预措施
Phase 1a:Dose escalation
JCXH-211 will be delivered by intratumoral injection in 3 stages:
Single administration stage A single administration of JCXH-211 administered to cutaneous or subcutaneous lesions in escalating doses.
Multiple administration stage Up to 3 doses of JCXH-211 administered to a cutaneous or subcutaneous lesion in escalating doses. Assigned dose to be determined on the data from the single administration arm.
Visceral administration stage JCXH-211 administered to a visceral lesion in escalating doses. Assigned dose to be determined on the data from the single and multiple administration arms.
干预措施: JCXH-211 (Drug)
Phase 1b:Dose expansion
JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase 1a.
干预措施: JCXH-211 (Drug)
结局指标
主要结局
Incidence of adverse events (Safety and Tolerability)
时间窗: From consent to 30 days after the last dose of study drug
Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)
Dose limiting toxicity
时间窗: Day 1 to Day 29
Dose limiting toxicity, evaluated in the single administration stage of Phase 1a, which will be used to determine the MTD and to determine dose escalation
次要结局
- Time to response (TTR)(Up to 12 months from the start of study therapy)
- Duration of response (DOR)(Up to 12 months following first reported response)
- Objective response rate (ORR)(Up to 12 months)
- Progression-free survival (PFS)(Up to 12 months)
- Overall survival (OS)(Up to 24 months)
- Disease control rate (DCR)(Up to 12 months)