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

Sponsor
ImmVira Pharma Co. Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05602792
Collaborator
(none)
233
Enrollment
19
Locations
1
Arm
44.4
Anticipated Duration (Months)
12.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: T3011
  • Biological: T3011
  • Biological: T3011
  • Biological: T3011
  • Biological: T3011
  • Biological: T3011
  • Biological: T3011
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
233 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Apr 21, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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. [Up to 2 years from first dose of T3011]

    Incidence rate of TEAE; Incidence rate of DLT

  2. 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. [Up to 2 years from first dose of T3011]

    Incidence rate of TEAE;

Secondary Outcome Measures

  1. 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]

    The changes of PD-1 and IL-12 concentration after administration

  2. In part I and part II, Evaluation of pharmacodynamics of T3011 [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

  3. In part I and part II, Evaluation of immunogenicity of T3011 [Up to 2 years from first dose of T3011]

    ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1

  4. Overall response rate (ORR) [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.

  5. Disease control rate (DCR) [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.

  6. Duration of response (DOR) [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.

  7. Progression-free survival (PFS) [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.

  8. In part III,Overall Survival (OS) [Up to 2 years from first dose of T3011]

    OS is defined as the time from enrollment to death from any cause.

Other Outcome Measures

  1. In part II and part III,Exploring tumor immunomodulatory mechanism and histological changes after IT T3011 [Up to 2 months from first dose of T3011]

    Assesse histological changes by immunohistochemical fluorescence detection

  2. In part II and part III,Exploring the relationship between genetic changes and drug efficacy [Up to 2 months from first dose of T3011]

    Genetic testing of tumor tissue

  3. In part II and part III,Exploring the proliferation and activity of immune cells in blood after IT T3011 [Up to 2 years from first dose of T3011]

    Analysis of immune cells in blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. 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.

  2. 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.

  3. 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.

  1. 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.

  2. Requires continued concurrent therapy with any drug active against HSV. 7. Pregnant or lactating.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Hospital Hefei Anhui China 230001
2 The Second Hospital of Anhui Medical University Hefei Anhui China 230601
3 The Fifth Affiliated Hospital of Sun Yat-sen University Guanzhou Guangdong China 528406
4 Henan Cancer Hospital Zhengzhou Henan China 450003
5 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
6 Wuhan Union Hospital Wuhan Hubei China 430022
7 Hunan Cancer Hospital Changsha Hunan China 410031
8 Jiangxi Cancer Hospital Nanchang Jiangxi China 330029
9 Liaoning Cancer Hospital Shenyang Liaoning China 110042
10 West China Hospital of Sichuan University Chengdu Sichuan China 610044
11 The First Affiliated Hospital of Zhejiang University Medical College Hanzhou Zhejiang China 310003
12 Zhejiang Provincial People's Hospital Hanzhou Zhejiang China 314408
13 Peking University First Hospital Beijing China 100034
14 Beijing Jishuitan Hospital Beijing China 100035
15 Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine Shanghai China 200011
16 Fudan University Cancer Hospital Shanghai China 200032
17 Zhongshan Hospital Shanghai China 200032
18 Shanghai Sixth People's Hospital Shanghai China 200233
19 The Second People's Hospital of Shenzhen Shenzhen China 518025

Sponsors and Collaborators

  • ImmVira Pharma Co. Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ImmVira Pharma Co. Ltd
ClinicalTrials.gov Identifier:
NCT05602792
Other Study ID Numbers:
  • TG1819ONC
First Posted:
Nov 2, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ImmVira Pharma Co. Ltd
Oncolytic virus
Herpes virus
Additional relevant MeSH terms:
Esophageal Neoplasms

Study Results

No Results Posted as of Nov 2, 2022