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Virus Therapy

T3011 + Pembrolizumab for Advanced Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by ImmVira Pharma Co. Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

• Pathologically confirmed, locally recurrent or metastatic solid tumors, including, but not limited to NSCLC, hepatocellular carcinoma, colorectal cancer, ovarian cancer and endometrial cancer (Phase 1).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from first dose of t3011

Awards & highlights

Study Summary

This trial is testing a new drug, T3011, to see if it's safe and effective in treating people with advanced solid tumors. The study will also compare T3011 given alone to T3011 given with another drug, pembrolizumab.

Who is the study for?

Adults with advanced solid tumors, including specific cancers like NSCLC and colorectal cancer, who have not responded to standard treatments. Participants must be in good health otherwise, with proper organ function and no severe immune deficiencies or active infections. Women of childbearing potential must use effective contraception.Check my eligibility

What is being tested?

The trial is testing T3011, both alone and combined with other therapies for treating various advanced solid tumors. It's an early-phase study that gradually increases the dose to find a safe level before expanding to more patients.See study design

What are the potential side effects?

While specific side effects are not listed here, similar cancer treatments often cause fatigue, nausea, inflammation at the injection site, allergic reactions or flu-like symptoms due to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a confirmed diagnosis of advanced cancer, such as lung, liver, colon, ovarian, or uterine cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood tests show normal white blood cells, platelets, and hemoglobin levels.

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My kidneys work well, with a creatinine clearance over 50 mL/min.

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It's been over 3 weeks since my last cancer treatment, surgery, or radiotherapy.

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My liver tests are within the normal range, or slightly above if I have Gilbert's Syndrome.

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I am 18 years old or older.

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My blood tests show normal white blood cells, platelets, and hemoglobin levels.

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I am a male either sterile or will use reliable birth control during and 6 months after the study.

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I am fully active or can carry out light work.

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My kidneys work well, with a creatinine clearance over 50 mL/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from first dose of t3011

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from first dose of t3011

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from first dose of t3011 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the safety and tolerability of escalating doses of single agent IV T3011 Characterize DLTs and identify the MTD and/or the RP2D of single agent IV T3011

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DOR)

Evaluate the immunogenicity of single agent IV T3011.

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 1Experimental Treatment1 Intervention

T3011 Single Agent Dose Escalation in participants with solid tumors

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmVira Pharma Co. LtdLead Sponsor

5 Previous Clinical Trials

490 Total Patients Enrolled

Media Library

Endometrial Cancer Research Study Groups: Phase 1

T3011 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04780217 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other research initiatives included T3011 in their investigations?

"T3011 was initially investigated at City of Hope in the year 2010, with 249 completed studies since then. Currently, there are 961 trials recruiting patients from numerous medical centres located primarily in Nashville, Tennessee."

Answered by AI

What is the geographic distribution of this clinical experiment?

"This investigation is being administered by the Sarah Cannon Research Institute in Nashville, Tennessee; Banner MD Anderson Cancer Center in Phoenix, Arizona; and Prisma Health - Upstate in Dallas, Texas as well as 5 other locations."

Answered by AI

Is recruitment currently underway for this experiment?

"Clinicaltrials.gov reports that this medical experiment is actively looking for participants to join in, with the trial initially posted on August 10th 2021 and last updated November 1st 2022."

Answered by AI

How many individuals are currently being observed in this trial?

"Affirmative. According to the details available on clinicaltrials.gov, this medical experiment is currently in search of its required participants. It was first posted on August 10th 2021 and received an update as recently as November 1st 2022. In total, 42 patients are needed from 5 different sites."

Answered by AI

Under what circumstances is the medication T3011 generally prescribed?

"T3011 is a frequently used pharmaceutical to treat malignant neoplasms. It can also be employed for the treatment of unresectable melanoma, microsatellite instability high, and post-chemotherapy disease progression."

Answered by AI

What are the anticipated results of this clinical experiment?

"The primary objective of this trial, assessed over a two-year period from the first dose of T3011 is to establish DLTs and determine the MTD or RD for single agent IV T3011 (Part A) as well as the MTD and/or RP2D when combined with pembrolizumab (Part B). Secondary endpoints such as PFS2, OS, and TTF will also be investigated. Specifically, PFS2 is measured from initiation of new antitumor therapy until either progression after treatment or death; OS measures time from enrollment to death due to any cause; finally, TTF"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravenous T3011 Given as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors

2021. "Intravenous T3011 Given as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04780217.

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