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Recruiting NCT06444815

A Study of VET3-TGI in Patients With Solid Tumors

Phase I Interventional Solid Tumor, Adult Microsatellite Stable Colorectal Cancer Head and Neck Squamous Cell Carcinoma Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VET3-TGI, Atezolizumab.
Who it may be relevant to
Registry conditions: Solid Tumor, Adult, Microsatellite Stable Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug VET3-TGI
    Oncolytic vaccinia virus engineered with immunomodulatory transgenes
  • Drug Atezolizumab
    anti-pd-L1 antibody

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • Efficacy assessment: overall response rate (ORR) [Time frame: 108 months]
  • Efficacy assessment: Duration of response (DOR) [Time frame: 108 months]
  • Efficacy assessment: disease control rate (DCR) [Time frame: 108 months]
  • Efficacy assessment: Time to tumor progression (TTP) [Time frame: 108 months]
  • Efficacy assessment: Progression free survival (PFS) [Time frame: 108 months]
  • Overall survival [Time frame: 108 months]
  • Immune changes in tissue and blood [Time frame: 6 weeks]
  • VET3-TGI delivery and replication kinetics [Time frame: 6 weeks]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • USC/Norris Comprehensive Cancer Center — Los Angeles
  • UC Irvine Health — Orange
  • University of Miami — Miami
  • Community Health Network — Indianapolis
  • UPMC- Hillman Cancer Center — Pittsburgh
  • Mary Crowley Cancer Research — Dallas
  • University of Texas MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06444815 · STEALTH-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗