Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06444815

A Study of VET3-TGI in Patients With Solid Tumors

Led by KaliVir Immunotherapeutics · Updated on 2026-04-07

60

Participants Needed

7

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).

CONDITIONS

Official Title

A Study of VET3-TGI in Patients With Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have pathologically confirmed advanced, unresectable, or metastatic solid tumors including breast, bladder, cervical, colorectal, esophageal, head and neck, renal, ovarian, sarcoma, thymoma, or uterine carcinoma
  • Failed, intolerant to, or refused curative treatment options such as molecularly targeted agents, immunotherapy, or chemotherapy
  • Have measurable disease according to RECIST 1.1 criteria
  • Have at least one tumor suitable for safe intratumoral injections and/or biopsies
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Demonstrate adequate organ function
  • Willing to comply with all study procedures and post-treatment care instructions
Not Eligible

You will not qualify if you...

  • Have not completed required washout periods from prior systemic therapies
  • Require anti-platelet or anti-coagulant therapy that cannot be safely stopped for biopsies or injections
  • Have untreated or incompletely treated central nervous system metastases or carcinomatous meningitis
  • Have a prior history of myocarditis
  • Have known HIV/AIDS or active hepatitis B or C infection
  • Are receiving high-dose immunosuppressive medications or have significant immunodeficiency such as transplant recipients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

2

UC Irvine Health

Orange, California, United States, 92868

Actively Recruiting

3

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

4

Community Health Network

Indianapolis, Indiana, United States, 46250

Actively Recruiting

5

UPMC- Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

6

Mary Crowley Cancer Research

Dallas, Texas, United States, 75230

Actively Recruiting

7

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Adina Pelusio

CONTACT

J

James Burke, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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A Study of VET3-TGI in Patients With Solid Tumors | DecenTrialz