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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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).
What is being tested
- VET3-TGI (drug)
- Atezolizumab (drug)
Sponsor: KaliVir Immunotherapeutics · Participants: 60 · Started: Sep 16, 2024
Contact the study team
- Adina Pelusio · Phone: +13057722084
Official record on ClinicalTrials.gov — NCT06444815
Locations in the U.S.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Cervical Cancer
- Kidney Cancer
- Kidney Cancer (Renal Cell Carcinoma)
- Melanoma
- Mesothelioma
- Non-Small Cell Lung Cancer
- Squamous Cell Carcinoma
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.