RECRUITING

A Study of VET3-TGI in Patients With Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-09-16
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06444815

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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
  3. * Measurable disease as per RECIST 1.1 criteria
  4. * At least one tumor amenable to safe ITu injections and/or biopsies
  5. * ECOG performance status 0 or 1
  6. * Demonstrate adequate organ function
  7. * Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions
  1. * Prior systemic therapy washout (dependent upon the therapy)
  2. * Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
  3. * CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
  4. * Prior history of myocarditis
  5. * Known HIV/AIDS, active HBV or HCV infection.
  6. * Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).

Contacts and Locations

Study Contact

Adina Pelusio
CONTACT
+13057722084
clinops@kalivir.com
James Burke, MD
CONTACT
clinops@kalivir.com

Study Locations (Sites)

USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Community Health Network
Indianapolis, Indiana, 46250
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: KaliVir Immunotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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