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A Study of VET3-TGI in Patients With Solid Tumors

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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).

What is being tested

Sponsor: KaliVir Immunotherapeutics · Participants: 60 · Started: Sep 16, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06444815

Locations in the U.S.

CaliforniaUSC/Norris Comprehensive Cancer Center, Los Angeles
UC Irvine Health, Orange
FloridaUniversity of Miami, Miami
IndianaCommunity Health Network, Indianapolis
PennsylvaniaUPMC- Hillman Cancer Center, Pittsburgh
TexasMary Crowley Cancer Research, Dallas
University of Texas MD Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.