A Study of VET3-TGI in Patients With Solid Tumors (STEALTH-001)

April 1, 2026 updated by: KaliVir Immunotherapeutics

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jacob Thomas, MD
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health
        • Principal Investigator:
          • Edward Uchio, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Jaime Merchan, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Principal Investigator:
          • Bert O'Neil, MD
        • Contact:
          • Patient Contact
          • Phone Number: 317-621-2627
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC- Hillman Cancer Center
        • Principal Investigator:
          • Yana Najjar, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Mary Crowley Cancer Research
        • Principal Investigator:
          • Minal Barve, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Siqing Fu, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: VET3-TGI alone intratumoral
Dose escalation of VET3-TGI alone administered by direct injection into tumor(s) x 4. Booster injections of VET3-TGI are permitted for up to 2 years.
Drug: VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Experimental: Group C: VET3-TGI alone intravenous
Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years.
Drug: VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Experimental: Group B: VET3-TGI intratumoral in combination with atezolizumab
VET3-TGI will be given in combination with atezolizumab at the highest tolerated dose from Group A. Atezolizumab will be administered via intravenous (IV) infusion for up to 2 years.
Drug: VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Drug: Atezolizumab
anti-pd-L1 antibody
Experimental: Group D: VET3-TGI intravenous in combination with atezolizumab
VET3-TGI will be given in combination with atezolizumab at the highest tolerated dose from Group C. Atezolizumab will be administered via intravenous (IV) infusion for up to 2 years.
Drug: VET3-TGI
Oncolytic vaccinia virus engineered with immunomodulatory transgenes
Drug: Atezolizumab
anti-pd-L1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab
Time Frame: 108 months
Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
108 months
Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab
Time Frame: 4 weeks
Number of dose limiting toxicities, as defined in the protocol, by dose group
4 weeks
Determine the recommended Phase 2 dose
Time Frame: 4 weeks
he highest dose of VET3-TGI in each group that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with atezolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy assessment: overall response rate (ORR)
Time Frame: 108 months
The number and proportion of patients with a partial response (PR) or complete response (CR) on imaging by RECIST 1.1
108 months
Efficacy assessment: Duration of response (DOR)
Time Frame: 108 months
Median duration of response in patients with a CR or PR
108 months
Efficacy assessment: disease control rate (DCR)
Time Frame: 108 months
The number and proportion of patients with stable disease (SD), or a partial response (PR) or complete response (CR) on imaging by RECIST 1.1
108 months
Efficacy assessment: Time to tumor progression (TTP)
Time Frame: 108 months
Median time until patient disease progression (PD)
108 months
Efficacy assessment: Progression free survival (PFS)
Time Frame: 108 months
Median duration of progression free survival of subjects
108 months
Overall survival
Time Frame: 108 months
median duration of survival across all subjects
108 months
Immune changes in tissue and blood
Time Frame: 6 weeks
number of subject tissue samples with immune cell infiltrates and heat map changes in the molecular signature of tissue samples
6 weeks
VET3-TGI delivery and replication kinetics
Time Frame: 6 weeks
Number of subject tissues with positive VET3-TGI gene signatures denoting delivery and complete replication of VET3-TGI
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KaliVir Immunotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEALTH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is aggregated.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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