Actively Recruiting
A Phase 1/1b Study of VET3-TGI Alone and with Atezolizumab in Patients with Advanced Solid Tumors
Led by KaliVir Immunotherapeutics · Updated on 2026-04-07
60
Participants Needed
7
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating VET3-TGI, an oncolytic immunotherapy designed to treat advanced solid tumors by infecting and killing cancer cells while sparing healthy cells. This Phase 1 dose escalation and expansion study aims to find a safe and effective dose of VET3-TGI administered either directly into tumors or intravenously, alone or combined with atezolizumab, in patients with various advanced solid tumors who have limited treatment options. The study includes four groups: Group A tests VET3-TGI alone by direct tumor injection; Group C tests VET3-TGI alone by intravenous infusion; Groups B and D combine VET3-TGI at the highest tolerated doses from Groups A and C with atezolizumab, an anti-PD-L1 antibody, given intravenously. Booster doses or infusions of VET3-TGI and atezolizumab may continue for up to two years. After determining the highest tolerated doses, up to 15 additional patients may be enrolled to further assess VET3-TGI's effects. Participants will undergo regular monitoring of safety through adverse event tracking and dose limiting toxicity assessments over several weeks and months. Researchers will evaluate tumor responses, disease control, progression, survival, immune changes in tissues and blood, and viral delivery kinetics. The study spans up to 108 months to capture long-term outcomes and safety, with participants expected to comply with study procedures and follow-up care throughout the treatment and observation periods.
CONDITIONS
Brief Title
A Study of VET3-TGI in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- 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
- Have failed, are intolerant to, or refused standard treatments such as chemotherapy, targeted agents, or immunotherapy
- Measurable disease by RECIST 1.1 criteria
- At least one tumor suitable for safe intratumoral injection or biopsy
- ECOG performance status of 0 or 1
- Demonstrate adequate organ function
- Willing to comply with study procedures and post-treatment care
You will not qualify if you...
- Not completed required washout period from prior systemic therapy
- Requires anti-platelet or anti-coagulant therapy that cannot be safely stopped for biopsies or tumor injections
- Presence of CNS metastases or carcinomatous meningitis not fully removed or treated
- History of myocarditis
- Known HIV/AIDS, active hepatitis B or C infection
- Receiving high-dose immunosuppressive medication or having significant immunodeficiency such as transplant recipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive VET3-TGI alone or in combination with atezolizumab through intratumoral injection or intravenous infusion. Booster injections or infusions may continue for up to 2 years.
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
Research Team
A
Adina Pelusio
J
James Burke, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here