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

Last updated: October 24, 2022
Sponsor: ImmVira Pharma Co. Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Liver Cancer

Lung Cancer

Lymphoma

Treatment

N/A

Clinical Study ID

NCT05598268
MVR-T3011-002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Locally recurrent or metastatic solid tumors, There is currently no effectivetreatment (including treatment intolerance).
  1. 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 pregnancytest at Screening within 7 days of dosing with T3011.
  2. Understand and sign ICF voluntarily,capable of understanding and complying withprotocol requirements.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 74
Study Start date:
March 01, 2022
Estimated Completion Date:
December 31, 2024

Study Description

This is a multicenter, open-label study conducted in 3 phases:

Dose escalation stage: The stage contains 4 cohorts, divided into cohort 1 (1x106PFU/ dose), cohort 2 (1x107PFU/ dose), cohort 3 (1x108PFU/ dose) and cohort 4 (3x108PFU/ dose). 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. At any dose level, if no DLT occurs among the first 3 subjects, then escalation to the next dose level may proceed, with the approval of the SMC. If 1 DLT occurs in the first 1 to 3 subjects, the dose level will expand to a maximum of 6 subjects. If no DLT occurs among the additional subjects, then escalation to the next dose level may proceed, with the approval of the SMC. If 2 or more DLTs occur within a cohort, then that dose level will be above the maximum tolerated dose (MTD) (the highest dose where no more than 1 of 6 subjects has experienced a DLT), and new subjects will be enrolled at the previous lower (tolerated) dose level until that cohort has 6 subjects. This lower dose level will be considered the MTD if ≤ 1 in 6 subjects has a DLT. At the end of dose escalation, the SMC will recommend a dose (the recommended phase 2 dose [RP2D]) of T3011 to be used in phase 2a expansion study based upon MTD identification, cumulative safety, pharmacokinetic (PK), efficacy, and pharmacodynamic data. Total enrollment will depend on the toxicities observed, with approximately 4-24 evaluable subjects enrolled in dose escalation stage.

In group A, participant will receive a single dose and the DLT evaluation period is 14 days.

In group B, Participants will receive administration at D1/D4/D8 of every cycle. The DLT evaluation period will be the first 21-day Cycle in group B. Tumor evaluation was performed every two cycles. The maximum treatment period should not exceed 4 cycles. Group B of cohort X was enrolled only after the DLT assessed for group A of cohort X and SMC approval to proceed to the next cohort assessment.

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.

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medicial College

    Bengbu, Anhui 233099
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guanzhou, Guangdong 510280
    China

    Active - Recruiting

  • the First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan 450052
    China

    Active - Recruiting

  • Henan Cancer Hosptial

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610044
    China

    Active - Recruiting

  • Beijing Chest Hospital

    Beijing, 101149
    China

    Active - Recruiting

  • Shanghai Chest Hosptial

    Shanghai, 200030
    China

    Active - Recruiting

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