A Study of T3011 Administered Via Intravenously in Patients With Advanced Solid Tumors.

NCT05598268 | Unknown Phase 1

• 1 other identifier: MVR-T3011-002
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 7

Brief Summary

This is a multicenter, open-label study conducted in 3 phases: Dose escalation stage: The stage contain 4 cohorts, each cohort divided into 2 groups （group A, single dose and Group B, multiple dose）.Dose escalation will use a 3+3 design to evaluate escalating doses of T3011.Cohorts of three subjects will be enrolled at each T3011 dose level with expansion to six subjects, if necessary, to assess toxicity. Total enrollment will depend on the toxicities observed, with approximately 4-24 evaluable subjects enrolled in dose escalation stage. Dose extension stage: The SMC will evaluate the available safety and preliminary efficacy data and initiate dose-expansion studies for the appropriate indications Phase IIa: To explore the safety of intravenous administration and expand the study in other indications. the stage will be carried out gradually based on the data obtained from the phase I study.

Conditions

Advanced Solid Tumor; Lung Cancer; Liver Cancer; Lymphoma; Mesothelioma of Pleura

Keywords

Herpes virus; Advanced solid tumor; Dose escalation; T3011; Oncolytic virus

Outcome Measures

Primary Outcomes (3)

• Evaluate the safety and tolerability of escalating doses of IV T3011 in Patients with advanced malignant tumors

  Incidence of AE(TEAE)

  Up to 2 years from first dose of T3011

• Assess DLTs and identify the RP2D of single agent IV T3011

  Incidence of DLT

  Up to 2 years from first dose of T3011

• Assess safety and tolerability of T3011 intravenous administration at MTD or RP2D doses through dose extension study

  Incidence of AE(TEAE)

  Up to 2 years from first dose of T3011

Secondary Outcomes (3)

• Evaluate the biodistribution and viral shedding of IV T3011

  Up to 2 years from first dose of T3011

• Evaluate the immunogenicity of IV T3011

  Up to 2 years from first dose of T3011

• Evaluate the preliminary clinical response of single agent IV T3011

  Up to 2 years from first dose of T3011

Other Outcomes (3)

• Exploring tumor immunomodulatory mechanism

  Up to 42 days from first dose of T3011

• Exploring histological changes after IT T3011

  Up to 42 days from first dose of T3011

• Exploring the relationship between genetic changes and drug efficacy

  Up to 42 days from first dose of T3011

Study Arms (1)

T3011 Herpes Virus Injection

EXPERIMENTAL

Biological: T3011

Interventions

T3011 BIOLOGICAL

T3011 will be administered through IV drip

T3011 Herpes Virus Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Locally recurrent or metastatic solid tumors, There is currently no effective treatment (including treatment intolerance).
• \. Age 18 years or older. 3. At least one target lesion per RECIST version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. 5. Life expectancy ≥ 12 weeks. 6. Women of childbearing potential must have a negative serum pregnancy test at Screening within 7 days of dosing with T3011.
• \. Understand and sign ICF voluntarily,capable of understanding and complying with protocol requirements.

You may not qualify if:

• \. Pregnant or lactating or plan to pregnant or give birth during the trial. 2. Splenectomy, previous allogenic organ transplant. 3. Prior treatment with another gene therapy（except T3011）. 4. Requires continued concurrent systemic therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Topical use of drugs against HSV are allowed.
• \. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody or their excipients.
• \. Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.

Sponsors & Collaborators

• ImmVira Pharma Co. Ltd: lead

Study Sites (7)

The First Affiliated Hospital of Bengbu Medicial College

Bengbu, Anhui, 233099, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guanzhou, Guangdong, 510280, China

RECRUITING

the First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 450052, China

RECRUITING

Henan Cancer Hosptial

Zhengzhou, Henan, 450003, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

Beijing Chest Hospital

Beijing, 101149, China

RECRUITING

Shanghai Chest Hosptial

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Liver Neoplasms; Lymphoma; Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms, Mesothelial; Pleural Neoplasms

Central Study Contacts

ImmVira Pharma Co. LTD

CONTACT

781-718-5121; clinicaltrials@immviragroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 28, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

CN (7)