A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
NCT ID: NCT05602792
Last Updated: 2022-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
233 participants
INTERVENTIONAL
2020-04-21
2024-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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T3011 Herpes Virus Injection
T3011
T3011 will be administered through intratumoral injection in patients with advanced solid tumors.
T3011
T3011 will be administered through intratumoral injection in patients with sarcoma.
T3011
T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.
T3011
T3011 will be administered through intratumoral injection in patients with breast cancer.
T3011
T3011 will be administered through intratumoral injection in patients with esophagus cancer.
T3011
T3011 will be administered through intratumoral injection in patients with lung cancer.
T3011
T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.
Interventions
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T3011
T3011 will be administered through intratumoral injection in patients with advanced solid tumors.
T3011
T3011 will be administered through intratumoral injection in patients with sarcoma.
T3011
T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.
T3011
T3011 will be administered through intratumoral injection in patients with breast cancer.
T3011
T3011 will be administered through intratumoral injection in patients with esophagus cancer.
T3011
T3011 will be administered through intratumoral injection in patients with lung cancer.
T3011
T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.
Eligibility Criteria
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Inclusion Criteria
3\. Measurable disease per RECIST version 1.1. 4. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
5\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Life expectancy \> 12 weeks. 7. 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 T3011.
8\. WCBP must have a negative serum pregnancy test Within 7 days prior to W1D1. 9. Capable of understanding and complying with protocol requirements.
Exclusion Criteria
4\. 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.
6\. Requires continued concurrent therapy with any drug active against HSV. 7. Pregnant or lactating.
18 Years
ALL
No
Sponsors
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ImmVira Pharma Co. Ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TG1819ONC
Identifier Type: -
Identifier Source: org_study_id
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