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A Study of VET3-TGI for Advanced Solid Tumors

This study is testing a new immunotherapy called VET3-TGI, which is a modified virus designed to infect and kill cancer cells while leaving healthy cells alone. It's being studied in adults with advanced, unresectable (cannot be removed by surgery), or metastatic (spread to other parts of the body) solid tumors, including cancers like colorectal, head and neck, cervical, and kidney cancer. Researchers want to find a safe and effective dose of VET3-TGI, given either directly into tumors or into a vein, both alone and in combination with another immunotherapy called atezolizumab. The main goal is to see how safe VET3-TGI is and to determine the best dose for future studies. This is the first time VET3-TGI is being given to human patients.

Study design
This is a Phase 1 study with about 60 participants. It's designed to find the highest tolerated dose of VET3-TGI, given alone or with atezolizumab, through different administration methods.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events for up to 108 months, and dose-limiting toxicities will be assessed for 4 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06444815

A Study of VET3-TGI in Patients With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
KaliVir Immunotherapeutics
~60 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:VET3-TGIAtezolizumab

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab
Measured over 108 months
+2 more outcomes measured

Conditions

Solid Tumor, Adult
Microsatellite Stable Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Cervical Cancer
Kidney Cancer
Renal Cell Carcinoma
Melanoma Stage IV
Merkel Cell Carcinoma of Skin
Mesothelioma
Non-small Cell Lung Cancer
Cutaneous Squamous Cell Carcinoma (CSCC)
Urothelial Carcinoma Bladder
Squamous Cell Carcinoma

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Where it's being run

7 sites across 5 states
California2
Texas2
Florida1
Indiana1
Pennsylvania1

Who to contact

Adina Pelusio
[email protected]
+13057722084
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.
Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy
Measurable disease as per RECIST 1.1 criteria
At least one tumor amenable to safe ITu injections and/or biopsies
ECOG performance status 0 or 1
Demonstrate adequate organ function
Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions

Exclusion

Prior systemic therapy washout (dependent upon the therapy)
Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
Prior history of myocarditis
Known HIV/AIDS, active HBV or HCV infection.
Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).

What this trial measures

  • Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab108 months

    Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0

  • Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab4 weeks

    Number of dose limiting toxicities, as defined in the protocol, by dose group

  • Determine the recommended Phase 2 dose4 weeks

    he highest dose of VET3-TGI in each group that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with atezolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation