A Study of VET3-TGI in Patients With Solid Tumors
Recruiting · NCT06444815 · Interventional (participants receive a specific treatment) · Lead sponsor: KaliVir Immunotherapeutics
View the official record on ClinicalTrials.gov →Interventions studied
AtezolizumabVET3-TGI
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
7 locations listed across 5 US states.
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- UC Irvine Health - Orange, California, United States
- University of Miami - Miami, Florida, United States
- Community Health Network - Indianapolis, Indiana, United States
- UPMC- Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- Mary Crowley Cancer Research - Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States