RecruitingPhase 1Phase 2NCT04370587

A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors


Sponsor

ImmVira Pharma Co. Ltd

Enrollment

30 participants

Start Date

Sep 17, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new virus-based cancer treatment called T3011, given directly into tumors, either alone or combined with the immunotherapy drug pembrolizumab. It is designed for people with advanced cancers including melanoma, head and neck cancer, sarcoma, skin squamous cell cancer, or lung cancer that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic melanoma, head and neck squamous cell cancer, sarcoma, cutaneous squamous cell cancer, or non-small cell lung cancer (without EGFR/ALK changes) - Your cancer has progressed on standard treatment - You have at least one tumor that can be injected - You are in generally good health and able to carry out daily activities - You have no active herpes lesions or herpes sores at the time of screening **You may NOT be eligible if...** - All your tumors are located where they cannot be injected - You have brain metastases - You have HIV, active hepatitis B or C - You previously received another oncolytic virus therapy or gene therapy - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding - You have had a prior organ transplant - You have active heart failure, unstable angina, or serious heart rhythm problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALT3011

T3011 will be administered up to 4mL as an intratumoral injection given Q2W.

COMBINATION_PRODUCTT3011 + pembrolizumab

T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.


Locations(9)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Southern Oncology

Bedford Park, Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Australia

The Alfred

Melbourne, Australia

View Full Details on ClinicalTrials.gov

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NCT04370587


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