NCT07682870尚未招募1 期
An Open-label, Multicenter Phase I/IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of VG2025 Intravenous Treatment in Subjects With Advanced Solid Tumors
Virogin Biotech Ltd.1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年9月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Safety：Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
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
- •Age 18 to 75 years (inclusive); Open to all genders.
- •Phase I: Participants with advanced solid tumors who have failed standard therapy (due to intolerance or disease progression following treatment) as confirmed by histopathology and/or cytology, or for whom no standard therapy is currently approved.
- •Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM).
- •Within 7 days prior to the first administration of the study drug, female participants of childbearing potential must confirm a negative serum pregnancy test. Participants of childbearing potential and their partners must agree to use effective contraception during the study drug administration period and for 90 days after the last dose.
排除标准
- •Participants experiencing an active herpes simplex virus (HSV) recurrence with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, or genital herpes; or those requiring anti-HSV treatment.
- •Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment.
- •Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional/ablation therapy within 4 weeks prior to the first dose.
- •Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en.
- •Any other serious underlying medical conditions, or mental or psychological disorders, hereditary diseases, etc., that, in the investigator's judgment, may interfere with disease staging, treatment, or follow-up; affect the participant's compliance; or place the participant at high risk.
- •Any other circumstances that, in the investigator's judgment, render the participant unsuitable for participation in the clinical trial.
结局指标
主要结局
Safety：Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 12 months
The assessment is conducted by monitoring the severity of AEs and SAEs during the study, including performing protocol-specified vital signs checks, physical examinations, 12-lead ECGs, laboratory tests, DLTs, and so on.
MTD/RP2D
时间窗: During the 28 day DLT observation period
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
次要结局
- Level of deoxyribonucleic acid (DNA)(12 months)
- Interleukin level(12 months)
- ORR(12 months)
- Duration of relief（DOR）(12 months)
- DCR(12 months)
- PFS(12 months)
- Immunogenicity Parameters(12 months)
- Efficacy and Safety of VG2025 and Its Correlation with CEA Levels(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A Clinical Study to Evaluate the Efficacy and Safety of VG2025 in Intrahepatic CholangiocarcinomaIntrahepatic CholangiocarcinomaNCT07522476Virogin Biotech Ltd.30
尚未招募
1 期
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 in Patients With Solid TumorsNCT07262164Shanghai Virogin Biotech Co., Ltd.30
招募中
1 期
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid TumorsAdvanced Malignant Solid TumorNCT05477849Shanghai Virogin Biotech Co., Ltd.30
招募中
4 期
Phase IV Clinical Study of sIPV Administration in Adolescent and Adult PopulationsNCT07354269Sinovac Biotech Co., Ltd180
招募中
1 期
Platform Study of VSV-Based Recombinant Oncolytic Viruses for the Treatment of Advanced Malignant TumorsNCT07656116Cancer Institute and Hospital, Chinese Academy of Medical Sciences27