← Back to Search

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).

Must not have

Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12

Primary or acquired immunodeficient states (leukemia, lymphoma, human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from first dose of t3011

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

I am fully active or can carry out light work.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with anti-PD-(L)1 and IL-12 before.

Select...

I have a condition that weakens my immune system, like leukemia, lymphoma, or HIV/AIDS.

Select...

I have had my spleen removed or received a transplant.

Select...

I am currently being treated for an infection.

Select...

I haven't taken high-dose steroids or immunosuppressants in the last 4 weeks.

Select...

I need ongoing treatment for herpes with specific antiviral drugs.

Select...

I do not have active herpes sores on my skin or mouth.

Select...

I have untreated brain or spinal cord cancer that is causing symptoms.

Select...

I have a serious heart condition, including heart failure or unstable angina.

Select...

I need treatment for fluid buildup in my chest or abdomen.

Select...

I had a bad reaction to immunotherapy or developed lung issues from it.

Select...

I have not had treatments like T-VEC, tumor vaccines, cellular therapy, or gene therapy.

Select...

I am allergic to certain components similar to HSV-1, IL-12, or anti-PD-1 treatments.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Disease control rate (DCR)

Duration of response (DOR)

Evaluate the immunogenicity of single agent IV T3011.

+5 more