Recruiting
Phase 1

VET3-TGI

Sponsor:

KaliVir Immunotherapeutics

Code:

NCT06444815

Conditions

Solid Tumor, Adult

Microsatellite Stable Colorectal Cancer

Head and Neck Squamous Cell Carcinoma

Cervical Cancer

Kidney Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VET3-TGI

Atezolizumab

Study Details

Brief 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).

Conditions

Solid Tumor, Adult

Microsatellite Stable Colorectal Cancer

Head and Neck Squamous Cell Carcinoma

Cervical Cancer

Kidney Cancer

Study ID

NCT06444815

Start date

Sep 16, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

VET3-TGI

Oncolytic vaccinia virus engineered with immunomodulatory transgenes

Atezolizumab

anti-pd-L1 antibody

Primary outcome measure

  • Incidence of adverse events with VET3-TGI alone or in combination with atezolizumab [ Time Frame: 108 months ]
  • Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with atezolizumab [ Time Frame: 4 weeks ]
  • Determine the recommended Phase 2 dose [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Adina Pelusio

+13057722084clinops@kalivir.com

James Burke, MD

clinops@kalivir.com

Locations

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Xiomara Menendez, RN

Xiomara.Menendez@med.usc.edu

Principal Investigator:

Jacob Thomas, MD

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Contacts

Patient Contact

clinops@kalivir.com

Principal Investigator:

Edward Uchio, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Patient contact

clinops@kalivir.com

Principal Investigator:

Jaime Merchan, MD

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Patient Contact

317-621-2627

Principal Investigator:

Bert O'Neil, MD

UPMC- Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Patient Contact

clinops@kalivir.com

Principal Investigator:

Yana Najjar, MD

Mary Crowley Cancer Research

Recruiting

Dallas, Texas, United States, 75230

Contacts

Minal Barve, MD

972-566-3000referral@marycrowley.org

Principal Investigator:

Minal Barve, MD

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Patient contact

ClinOps@KaliVir.com

Principal Investigator:

Siqing Fu, MD, PhD

More Information

Sponsor

KaliVir Immunotherapeutics

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by KaliVir Immunotherapeutics on 2026-04-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.