Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around
Principal Investigator
by Edward Uchio, MD (uci)

Description

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 pembrolizumab in patients with solid tumors (STEALTH-001).

Official Title

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

Details

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 pembrolizumab. 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.

Keywords

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, Merkel Cell Carcinoma, Carcinoma, Squamous Cell Carcinoma of Head and Neck, Kidney Neoplasms, Pembrolizumab, VET3-TGI, VET3-TGI alone intratumoral, VET3-TGI alone intravenous

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC Irvine Health accepting new patients
    Orange California 92868 United States
  • USC/Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Edward Uchio, MD (uci)
    Clinical Professor, Urology, School of Medicine. Authored (or co-authored) 82 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
KaliVir Immunotherapeutics
ID
NCT06444815
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated