复发或难治性卵巢癌患者的 GL-ONC1 溶瘤免疫疗法
2026年5月18日 更新者：Genelux Corporation
GL-ONC1 溶瘤免疫治疗复发或难治性卵巢癌患者的 1b 期和 2 期研究 (VIRO-15)
本研究的目的是确定 GL-ONC1 溶瘤免疫疗法在诊断为复发性或难治性卵巢癌和腹膜癌病的患者中是否具有良好的抗肿瘤活性耐受性。
研究概览
详细说明
由于发现晚、内在和获得性化疗耐药以及显着的异质性，卵巢癌 (OC) 仍然是最致命的妇科恶性肿瘤。
开发新治疗方式的医疗需求尚未得到满足。
在临床前研究中，GL-ONC1已显示出优先定位、定植和破坏 30 多种不同人类肿瘤（包括卵巢癌）中的肿瘤细胞的能力。
GL-ONC1已在美国和欧洲的早期临床试验中通过全身给药作为单一疗法并与其他疗法联合，以及通过区域给药作为单一疗法进行了研究。
GL-ONC1治疗在不同的恶性肿瘤、给药途径、单一疗法以及联合疗法方案中均具有良好的耐受性。
证明了 GL-ONC1 感染肿瘤组织和杀死肿瘤细胞的能力。
此外，已经观察到病毒诱导的免疫激活和有利的抗肿瘤免疫反应。
还记录了抗肿瘤功效和临床益处的证据。
研究类型
介入性
注册 (实际的)
46
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Newport Beach、California、美国、92663
- Gynecologic Oncology Associates
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Florida
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Orlando、Florida、美国、32804
- AdventHealth Cancer Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 签署书面知情同意书。
- 高级别浆液性（包括恶性混合性苗勒氏管肿瘤 (MMMT)，伴有高级别上皮癌转移）、子宫内膜样癌或透明细胞卵巢癌，包括：(1) 铂类耐药（<6 个月内复发或进展）或(2) 铂难治性（在铂类治疗期间进展）；患者必须至少连续 2 次治疗失败或不符合额外细胞毒性治疗的条件（接受化疗加/不加贝伐珠单抗的第 2 期除外）。
- 中等铂类敏感患者（自上次铂类化合物治疗后 6 至 12 个月疾病复发）：复发性卵巢癌，至少有四种先前的个体治疗方案，包括至少两种独立的铂类疗法，并且从最后一次基于铂类的方案中复发较少超过 12 个月，不愿或不能接受额外的基于铂的细胞毒性治疗（该亚群不适用于接受有/无贝伐珠单抗化疗的第 2 期）。
- 体能状态 ECOG 为 0 或 1，预期寿命为 6 个月
- 根据 RECIST 1.1（1b 和 2 期）的定义，腹腔内有可测量的疾病，或者腹腔内有不可测量的疾病（1b 期），并且可以通过腹腔镜检查和/或 CA-125 升高来确认。 患有 PET/PET-CT 扫描无法识别的不可测量疾病但 CA-125 升高和/或腹水且经腹腔镜检查确认可见疾病的患者也符合资格。
- 能够进行 IP 注入。
- 足够的肾、肝、骨髓和免疫功能。
- 需要进行基线肿瘤活检。
- 记录在基线时的疾病进展状态（第 2 阶段）。
排除标准：
- 粘液亚型肿瘤或非上皮性卵巢癌（例如 Brenner 肿瘤、性索肿瘤）。
- 未解决的肠梗阻。
- 已知的中枢神经系统 (CNS) 转移。
- 已知的 HIV 或活动性肝炎感染血清阳性。
- 最近 3 个月内有血栓栓塞事件史。
- 孕妇或哺乳期妇女。
- 研究治疗后 1 年内接种天花疫苗。
- 有临床意义的心脏病。
- 接受过任何类型的细胞溶解病毒的先前基因治疗或治疗。
- 接受同时具有抗痘苗病毒活性的抗病毒剂。
- 已知对卵清蛋白或其他蛋制品过敏。
- 根据研究者的评估，患有具有临床意义的皮肤病（例如，湿疹、牛皮癣或未愈合的皮肤伤口或溃疡）。
- 有症状的恶性腹水和难以控制的胸腔积液。
- 已知对贝伐珠单抗过敏、未控制的高血压、中风病史或提示 GL 穿孔风险过高的临床发现（未控制的消化性溃疡病、部分小肠梗阻等），这将使研究者认为贝伐珠单抗的风险不可接受。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Phase 1b - Cohort 1
Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu.
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Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
其他名称：
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实验性的：Phase 1b - Cohort 2
Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu.
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Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
其他名称：
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实验性的：Phase 1b - Cohort 3
Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu.
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Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
其他名称：
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实验性的：Phase 2
Participants treated in the Phase 2 portion received 2 IP infusions of Olvi-Vec at 3 x 10e9 pfu followed by platinum-doublet chemotherapy with or without bevacizumab.
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Olvi-Vec is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
其他名称：
Carboplatin + choice of non-platinum chemotherapy drug: taxane, paclitaxel, nab-paclitaxel, gemcitabine or doxorubicin pegylated liposomal with or without bevacizumab.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b)
大体时间：Change from baseline during Treatment and for 30 days following last dose over average of 2 years.
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Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
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Change from baseline during Treatment and for 30 days following last dose over average of 2 years.
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Progression-free Survival Following Treatment in Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer.
大体时间：For participants enrolled in the Phase 2 portion, outcome is from the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
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Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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For participants enrolled in the Phase 2 portion, outcome is from the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
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Overall Response Rate (ORR) by Tumor Marker Cancer Antigen-125 (CA-125) for Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer
大体时间：Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.
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To assess anti-tumor response by Overall Response Rate by Tumor Marker Cancer Antigen-125 (CA-125) for participants who were enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer.
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Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.
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Overall Response Rate (ORR) by RECIST 1.1 for Participants Enrolled in the Phase 2 Portion of the Study With Platinum-resistant or Platinum-refractory Ovarian Cancer
大体时间：For evaluable participants enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer who were assessed at pre-treatment, during treatment at 6- to 12-week intervals and post-treatment up to 24 months.
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To assess anti-tumor response by Overall Response Rate (ORR) defined as disease control rate (DCR = CR + PR + SD≥15 weeks) by RECIST 1.1 criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
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For evaluable participants enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer who were assessed at pre-treatment, during treatment at 6- to 12-week intervals and post-treatment up to 24 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study
大体时间：Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
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Participants enrolled in the Phase 1b study were assessed for best overall response to treatment with therapeutic intent by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
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Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
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CA-125 Response in Participants Enrolled in the Phase 1b Portion of This Study
大体时间：Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months.
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CA-125 according to the Gynecologic Cancer Intergroup (GCIG) is measured by at least a 50% reduction in CA-125 levels from pre-treatment sample which is confirmed and maintained for at least 28 days.
Pre-treatment CA-125 sample must be at least twice the upper limit of normal and obtained within 2 weeks prior to starting treatment.
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Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months.
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Determine Progression-free Survival Following Treatment (Phase 1b)
大体时间：From the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
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To assess the number of months of progression-free survival (PFS) by RECIST 1.1.
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From the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
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Overall Survival
大体时间：By medical chart review until death or 3 years from the date of last treatment whichever comes first.
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To determine overall survival (OS) in the participant population.
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By medical chart review until death or 3 years from the date of last treatment whichever comes first.
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Clinical Benefit Rate
大体时间：Approximately 24 months
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Defined as the percentage of patients who have achieved CR + PR + SD by RECIST 1.1.
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Approximately 24 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of Immune-related Tumor Response
大体时间：Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
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This exploratory outcome measure evaluates participants' best overall response to treatment with oncolytic immunotherapy assessed by Immune-related Response Criteria (immune-related complete response, immune-related partial response, immune-related stable disease, or immune-related progressive disease).
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Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年5月1日
初级完成 (实际的)
2021年12月31日
研究完成 (实际的)
2022年12月31日
研究注册日期
首次提交
2016年4月25日
首先提交符合 QC 标准的
2016年4月29日
首次发布 (估计的)
2016年5月3日
研究记录更新
最后更新发布 (实际的)
2026年6月12日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- GL-ONC1-015
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