NCT06444815RecruitingPhase 1
A Study of VET3-TGI in Patients With Solid Tumors
A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 May 2024
- Start date
- 16 Sept 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- KaliVir Immunotherapeutics
- Diseases
- Head and neck cancer, Mesothelioma, Kidney cancer, Bladder cancer, Melanoma, Cervical cancer, Lung cancer, Colorectal cancer
- NCT number
- NCT06444815
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 16 Sept 2024 to the primary completion date, 30 Sept 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known HIV/AIDS, active HBV or HCV infection.
Lab values
- Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
Other
- CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Community Health Network Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| UC Irvine Health Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.