A Phase I/IIa Study to Assess the Safety, Tolerability, Biodistribution and Pharmacodynamic of T3011 Herpes Virus Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 233
- 试验地点
- 23
- 主要终点
- In part III, Evaluate the safety of multiple dose IT T3011 in the following indications,including sarcoma, Malignant head and neck tumor, breast cancer, esophagus cancer, lung cancer and non-melanoma skin cancer.
研究概览
简要总结
A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors
详细描述
This is a Phase I/IIa, open-label, first-in-human study of T3011 given via intratumoral (IT) injection in participants with advanced or metastatic solid tumors. Part I and part II of the study is a dose escalation which will use a 3+3 design to evaluate escalating doses of T3011. Part I is a single dose escalation. Part II is multiple dose escalation. Total enrollment will depend on the toxicities and/or activity observed, with approximately 8-48 evaluable participants enrolled.
Once the RP2D is established ,Part III will enroll approximately 40-60 participants with sarcoma , approximately 10-25 participants with Malignant head and neck tumor,approximately 10-25 participants with breast cancer,approximately 10-25 participants with esophagus cancer,approximately 10-25 participants with lung cancer and approximately 10-25 participants with non-melanoma skin cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Age 18~70 years Part I ; Age 18 years or older (Part II and III ).
- •Histologically or pathologically confirmed diagnosis of locally recurrent or metastatic advanced malignancy.
- •Measurable disease per RECIST version 1.
- •Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Life expectancy > 12 weeks.
- •Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T
- •WCBP must have a negative serum pregnancy test Within 7 days prior to W1D
- •Capable of understanding and complying with protocol requirements.
排除标准
- •Last dose of previous anticancer therapy < 4 weeks.
- •Prior treatment with another oncolytic virus or gene therapy.
- •Previous intolerance to anti-PD-(L)1 monoclonal antibody or previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease.
- •History of seizure disorders within 12 months of Screening. 5.History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
- •Requires continued concurrent therapy with any drug active against HSV.
- •Pregnant or lactating.
结局指标
主要结局
In part III, Evaluate the safety of multiple dose IT T3011 in the following indications,including sarcoma, Malignant head and neck tumor, breast cancer, esophagus cancer, lung cancer and non-melanoma skin cancer.
时间窗: Up to 2 years from first dose of T3011
Incidence rate of TEAE;
In part I and part II, Evaluate the safety and tolerability of escalating doses of single dose and multiple dose IT T3011.Characterize DLTs and identify the MTD of IT T3011.
时间窗: Up to 2 years from first dose of T3011
Incidence rate of TEAE; Incidence rate of DLT
次要结局
- In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.(Up to 2 years from first dose of T3011)
- In part I and part II, Evaluation of immunogenicity of T3011(Up to 2 years from first dose of T3011)
- Duration of response (DOR)(Up to 2 years from first dose of T3011)
- In part I and part II, Evaluation of pharmacodynamics of T3011(Up to 2 years from first dose of T3011)
- Overall response rate (ORR)(Up to 2 years from first dose of T3011)
- In part III,Overall Survival (OS)(Up to 2 years from first dose of T3011)
- Disease control rate (DCR)(Up to 2 years from first dose of T3011)
- Progression-free survival (PFS)(Up to 2 years from first dose of T3011)