Spots Global Cancer Trial Database for A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
Official Title: 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.
Study ID: NCT05602792
Study Description
Brief Summary: A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Anhui Provincial Hospital, Hefei, Anhui, China
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
The Fifth Affiliated Hospital of Sun Yat-sen University, Guanzhou, Guangdong, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Wuhan Union Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jiangxi Cancer Hospital, Nanchang, Jiangxi, China
Liaoning Cancer Hospital, Shenyang, Liaoning, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
The First Affiliated Hospital of Zhejiang University Medical College, Hanzhou, Zhejiang, China
Zhejiang Provincial People's Hospital, Hanzhou, Zhejiang, China
Peking University First Hospital, Beijing, , China
Beijing Jishuitan Hospital, Beijing, , China
Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine, Shanghai, , China
Fudan University Cancer Hospital, Shanghai, , China
Zhongshan Hospital, Shanghai, , China
Shanghai Sixth People's Hospital, Shanghai, , China
The Second People's Hospital of Shenzhen, Shenzhen, , China
Contact Details
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