A Study of T3011 Administered Via Intravenously in Patients With Advanced Solid Tumors.
NCT ID: NCT05598268
Last Updated: 2022-10-28
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
74 participants
INTERVENTIONAL
2022-03-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
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 IV drip
Interventions
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T3011
T3011 will be administered through IV drip
Eligibility Criteria
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Inclusion Criteria
2\. 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.
7\. Understand and sign ICF voluntarily,capable of understanding and complying with protocol requirements.
Exclusion Criteria
5\. 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.
6\. Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
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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The First Affiliated Hospital of Bengbu Medicial College
Bengbu, Anhui, China
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, China
the First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Henan Cancer Hosptial
Zhengzhou, Henan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Beijing Chest Hospital
Beijing, , China
Shanghai Chest Hosptial
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MVR-T3011-002
Identifier Type: -
Identifier Source: org_study_id
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