A Study of VET3-TGI in Patients With Solid Tumors

Description

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).

Conditions

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

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Study Overview

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Study Details

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

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

A Study of VET3-TGI in Patients With Solid Tumors

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Indianapolis

Community Health Network, Indianapolis, Indiana, United States, 46250

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

KaliVir Immunotherapeutics,

Study Record Dates

2027-12-31