Trials / Recruiting
RecruitingNCT06444815
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- KaliVir Immunotherapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
VET3-TGI was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. This is a Phase 1 dose escalation (and expansion) study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation has 4 groups: the first group (Group A) will determine the highest tolerated dose of VET3-TGI when injected into tumor(s); the second group (Group C) will determine the highest tolerated dose of VET3-TGI when infused into the vein. The third and fourth groups (Group B and D) will combine VET3-TGI with atezolizumab. These groups will begin at the highest tolerated dose determined in Group B and Group D, respectively. Once the highest tolerated dose is found for each of these groups, that dose may be expanded to up to 15 additional patients to better examine the efficacy of VET3-TGI.
Conditions
- Solid Tumor, Adult
- Microsatellite Stable Colorectal Cancer
- Head and Neck Squamous Cell Carcinoma
- Cervical Cancer
- Kidney Cancer
- Renal Cell Carcinoma
- Melanoma Stage IV
- Merkel Cell Carcinoma of Skin
- Mesothelioma
- Non-small Cell Lung Cancer
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Urothelial Carcinoma Bladder
- Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VET3-TGI | Oncolytic vaccinia virus engineered with immunomodulatory transgenes |
| DRUG | Atezolizumab | anti-pd-L1 antibody |
Timeline
- Start date
- 2024-09-16
- Primary completion
- 2027-09-30
- Completion
- 2027-12-31
- First posted
- 2024-06-06
- Last updated
- 2026-04-07
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06444815. Inclusion in this directory is not an endorsement.