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Recruiting Phase 1

A Study of VET3-TGI in Patients With Solid Tumors

NCT06444815 · tracked via the Priya Life Science USA tracker
Sponsor
KaliVir Immunotherapeutics
Phase
Phase 1
Started
2024-09-16
Last updated
2026-04-07

Condition(s) studied

Solid Tumor, AdultMicrosatellite Stable Colorectal CancerHead and Neck Squamous Cell CarcinomaCervical CancerKidney CancerRenal Cell CarcinomaMelanoma Stage IVMerkel Cell Carcinoma of SkinMesotheliomaNon-small Cell Lung CancerCutaneous Squamous Cell Carcinoma (CSCC)Urothelial Carcinoma BladderSquamous Cell Carcinoma

Investigational drug(s) / intervention(s)

VET3-TGIAtezolizumab →

VET3-TGI: Oncolytic vaccinia virus engineered with immunomodulatory transgenes

Atezolizumab: anti-pd-L1 antibody

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * 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 Additional Inclusion criteria exist Key Exclusion Criteria: * 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). Additional Exclusion criteria exist

Primary outcome measure(s)

  • Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab — 108 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 atezolizumab — 4 weeks
    Number of dose limiting toxicities, as defined in the protocol, by dose group
  • Determine the recommended Phase 2 dose — 4 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

Trial sites (7)

FacilityCityRegionStatus
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
UC Irvine Health Orange California Recruiting
University of Miami Miami Florida Recruiting
Community Health Network Indianapolis Indiana Recruiting
UPMC- Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Mary Crowley Cancer Research Dallas Texas Recruiting
University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06444815 on ClinicalTrials.gov ↗ ← All trials in the USA