A Study of VET3-TGI in Patients With Solid Tumors

ConditionsSolid 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 Cutaneous Squamous Cell Carcinoma (CSCC)Urothelial Carcinoma Bladder Squamous Cell Carcinoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorKaliVir Immunotherapeutics

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

VET3-TGI
Atezolizumab

Treatment groups

60 Participants

are divided into 4 treatment groups

Locations

USC/Norris Comprehensive Cancer Center90033, Los AngelesCalifornia, United States

UC Irvine Health92868, OrangeCalifornia, United States

University of Miami33136, MiamiFlorida, United States

Community Health Network46250, IndianapolisIndiana, United States

Sponsors and collaborators

KaliVir Immunotherapeutics

Lead sponsor

Source ClinicalTrials.gov