Testing VET3-TGI, alone or with atezolizumab, in adults with advanced solid tumors
Tests VET3-TGI, a new treatment, alone or with atezolizumab, in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: A Study of VET3-TGI in Patients With Solid Tumors
Key facts
- Where
- Dallas, Houston, Indianapolis, Los Angeles, Miami, Orange, and Pittsburgh, United StatesSee the 7 sites
- Phase
- Phase 1
Where in United States
- Mary Crowley Cancer ResearchDallas, United StatesTaking people
- University of Texas - MD Anderson Cancer CenterHouston, United StatesTaking people
- Community Health NetworkIndianapolis, United StatesTaking people
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- University of MiamiMiami, United StatesTaking people
- UC Irvine HealthOrange, United StatesTaking people
- UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- KaliVir Immunotherapeutics
- Trial code
- NCT06444815
- Record updated
- 7 April 2026
- Original description
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).Read full original descriptionShow less
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
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).
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; Additional Inclusion criteria exist.
Exclusion: Prior systemic therapy washout (dependent upon the therapy); Prior history of myocarditis; Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc); Additional Exclusion criteria exist; Known HIV/AIDS, active HBV or HCV infection; 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.