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Monoclonal Antibodies

T3011 + Pembrolizumab for Solid Cancers

Phase 1 & 2
Recruiting
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
Capable of understanding and complying with protocol requirements
Age 18 years or older
Must not have
Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias
History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from first dose of t3011
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

Who is the study for?
Adults with advanced solid tumors who've had disease progression after standard treatments or are unlikely to benefit from them. They must have a tumor lesion suitable for injection, a life expectancy over 12 weeks, and agree to use contraception. Exclusions include pregnancy, certain allergies, active infections like COVID-19, recent vaccines, immunodeficiencies, organ transplants, some heart conditions.
What is being tested?
The trial is testing T3011 alone and combined with pembrolizumab in patients with various advanced cancers. It's an early-phase study assessing safety and initial effectiveness of these treatments administered directly into the tumor (T3011) and intravenously (pembrolizumab).
What are the potential side effects?
Potential side effects may include reactions at the injection site for T3011, typical immune-related adverse events from pembrolizumab such as fatigue, skin rash or itching; digestive issues; lung inflammation; hormonal gland problems; muscle pain or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand and can follow the study's requirements.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer has returned or spread and this was confirmed by a lab test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart conditions like heart failure or unstable angina.
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I am allergic to certain virus-based therapies or immune system drugs.
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I am currently infected with COVID-19.
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I have or had cancer spread to my brain or spinal cord.
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I had a bad reaction to previous immunotherapy or developed lung issues from it.
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I currently have an active herpes sore.
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I haven't taken steroids or immunosuppressants in the last 4 weeks.
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I have or had lung inflammation treated with steroids.
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I have previously received treatments like tumor vaccines or gene therapy.
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My cancer has spread to more than 3 areas or my largest tumor is bigger than 3 cm (non-sarcoma)/5 cm (sarcoma).
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I need to keep taking medication for herpes.
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I need treatment for fluid buildup in my chest or abdomen.
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My tumor is pressing on major airways or blood vessels.
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My tumors cannot be treated with injections.
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My previous radiation treatment included the area around my carotid artery.
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I have had an organ transplant.
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I have been treated with anti-PD-(L)1 and IL-12 before.

Timeline

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
Characterize the safety and tolerability of T3011 in combination with pembrolizumab
Characterize the safety and tolerability of T3011 in combination with pembrolizumab in participants who progress on T3011 alone
Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts
+2 more
Secondary study objectives
Disease control rate (DCR)
Durable response (DR)
Duration of response (DOR)
+5 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Rollover ArmExperimental Treatment1 Intervention
RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent
Group II: Phase 2a Part 2 Arm CExperimental Treatment1 Intervention
RP2D T3011 + pembrolizumab in participants with NSCLC
Group III: Phase 2a Part 1 Arm BExperimental Treatment1 Intervention
RP2D T3011 single agent in participants with other solid tumors
Group IV: Phase 2a Part 1 Arm AExperimental Treatment1 Intervention
RP2D T3011 single agent in participants with melanoma
Group V: Phase 1Experimental Treatment1 Intervention
T3011 single agent dose escalation in participants with solid tumors

Find a Location

Who is running the clinical trial?

ImmVira Pharma Co. LtdLead Sponsor
5 Previous Clinical Trials
468 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04370587 — Phase 1 & 2
Soft Tissue Sarcoma Research Study Groups: Phase 1, Phase 2a Part 1 Arm A, Phase 2a Part 2 Arm C, Rollover Arm, Phase 2a Part 1 Arm B
Soft Tissue Sarcoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04370587 — Phase 1 & 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04370587 — Phase 1 & 2
~12 spots leftby Dec 2025
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