A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors

October 30, 2022 updated by: ImmVira Pharma Co. Ltd

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.

A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

233

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
      • Beijing, China, 100035
      • Shanghai, China, 200032
      • Shanghai, China, 200032
      • Shanghai, China, 200011
        • Recruiting
        • Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine
        • Contact:
      • Shanghai, China, 200233
      • Shenzhen, China, 518025
    • Anhui
      • Hefei, Anhui, China, 230001
      • Hefei, Anhui, China, 230601
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
    • Guangdong
      • Guanzhou, Guangdong, China, 528406
        • Recruiting
        • The Fifth Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
    • Hunan
      • Changsha, Hunan, China, 410031
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
    • Liaoning
      • Shenyang, Liaoning, China, 110042
    • Sichuan
      • Chengdu, Sichuan, China, 610044
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University Medical College
        • Contact:
      • Hanzhou, Zhejiang, China, 314408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Age 18~70 years Part I ; Age 18 years or older (Part II and III ). 2. Histologically or pathologically confirmed diagnosis of locally recurrent or metastatic advanced malignancy.

    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:

  • 1. Last dose of previous anticancer therapy < 4 weeks. 2. Prior treatment with another oncolytic virus or gene therapy. 3. Previous intolerance to anti-PD-(L)1 monoclonal antibody or previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease.

    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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T3011 Herpes Virus Injection
Biological: T3011
T3011 will be administered through intratumoral injection in patients with advanced solid tumors.
Biological: T3011
T3011 will be administered through intratumoral injection in patients with sarcoma.
Biological: T3011
T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.
Biological: T3011
T3011 will be administered through intratumoral injection in patients with breast cancer.
Biological: T3011
T3011 will be administered through intratumoral injection in patients with esophagus cancer.
Biological: T3011
T3011 will be administered through intratumoral injection in patients with lung cancer.
Biological: T3011
T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Up to 2 years from first dose of T3011
Incidence rate of TEAE; Incidence rate of DLT
Up to 2 years from first dose of T3011
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.
Time Frame: Up to 2 years from first dose of T3011
Incidence rate of TEAE;
Up to 2 years from first dose of T3011

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.
Time Frame: Up to 2 years from first dose of T3011
The changes of PD-1 and IL-12 concentration after administration
Up to 2 years from first dose of T3011
In part I and part II, Evaluation of pharmacodynamics of T3011
Time Frame: Up to 2 years from first dose of T3011
IFN-γ、 IL-1β、 IL-2、 IL-4、 IL-6、 IL-8、 IL-10、 IL-13、 TNF-α
Up to 2 years from first dose of T3011
In part I and part II, Evaluation of immunogenicity of T3011
Time Frame: Up to 2 years from first dose of T3011
ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1
Up to 2 years from first dose of T3011
Overall response rate (ORR)
Time Frame: Up to 2 years from first dose of T3011
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
Up to 2 years from first dose of T3011
Disease control rate (DCR)
Time Frame: Up to 2 years from first dose of T3011
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
Up to 2 years from first dose of T3011
Duration of response (DOR)
Time Frame: Up to 2 years from first dose of T3011
DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
Up to 2 years from first dose of T3011
Progression-free survival (PFS)
Time Frame: Up to 2 years from first dose of T3011
PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST.
Up to 2 years from first dose of T3011
In part III,Overall Survival (OS)
Time Frame: Up to 2 years from first dose of T3011
OS is defined as the time from enrollment to death from any cause.
Up to 2 years from first dose of T3011

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
In part II and part III,Exploring tumor immunomodulatory mechanism and histological changes after IT T3011
Time Frame: Up to 2 months from first dose of T3011
Assesse histological changes by immunohistochemical fluorescence detection
Up to 2 months from first dose of T3011
In part II and part III,Exploring the relationship between genetic changes and drug efficacy
Time Frame: Up to 2 months from first dose of T3011
Genetic testing of tumor tissue
Up to 2 months from first dose of T3011
In part II and part III,Exploring the proliferation and activity of immune cells in blood after IT T3011
Time Frame: Up to 2 years from first dose of T3011
Analysis of immune cells in blood
Up to 2 years from first dose of T3011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmVira Pharma Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 30, 2022

First Posted (Actual)

November 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 30, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG1819ONC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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