Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06444815

A Study of VET3-TGI in Patients With 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Solid Tumor, Adult Adenocarcinoma Adenoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Cervical Cancer Cutaneous Squamous Cell Carcinoma (CSCC) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Kidney Cancer Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Melanoma Stage IV Merkel Cell Carcinoma of Skin Mesothelioma Microsatellite Stable Colorectal Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Bladder Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VET3-TGI

Drug

Oncolytic vaccinia virus engineered with immunomodulatory transgenes

Atezolizumab

Drug

anti-pd-L1 antibody

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. Efficacy assessment: Duration of response (DOR)

    Time frame: 108 months

    Median duration of response in patients with a CR or PR

  3. 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

  4. Efficacy assessment: Time to tumor progression (TTP)

    Time frame: 108 months

    Median time until patient disease progression (PD)

  5. Efficacy assessment: Progression free survival (PFS)

    Time frame: 108 months

    Median duration of progression free survival of subjects

  6. Overall survival

    Time frame: 108 months

    median duration of survival across all subjects

  7. 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

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Adina Pelusio

CONTACT

[email protected]

+13057722084

James Burke, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

KaliVir Immunotherapeutics

Industry

Registry information

Official study title

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors

Acronym: STEALTH-001

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.