ACTIVE_NOT_RECRUITING

A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors

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Conditions

Solid TumorSolid CarcinomaSolid Tumor, AdultMetastatic CancerAdvanced Solid TumorCholangiocarcinomaBile Duct Canceroncolytic virus

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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

This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab or mFOLFOX in patients with metastatic or advanced solid tumors.

Official Title

A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Metastatic or Advanced Solid Tumors (MAST).

Quick Facts

Study Start:2022-05-17
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05346484

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. * Written informed consent from patient or legally authorized representative
  2. * Age ≥ 18 years old on the date of consent
  3. * IT/IV cohorts: Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor (ICI) treatment). Expansion cholangiocarcinoma IT and IV cohorts: one prior line of chemotherapy in metastatic/advanced setting. Patients with targetable tumor mutations must have also received 1 line of approved targeted therapy.
  4. * Expansion cholangiocarcinoma IV cohort: prior treatment with leucovorin calcium, fluorouracil, or oxaliplatin is not permitted.
  5. * ECOG performance status 0 - 2
  6. * At least one measurable lesion
  7. * For IT administration, ideally \< 5 total lesions no greater than 10cm and \<33% of liver volume replaced by tumor.
  8. * Adequate renal function
  9. * Adequate liver function
  10. * Adequate hematologic function
  11. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  1. * Prior treatment with a poxvirus based oncolytic virus.
  2. * Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
  3. * Prior radiotherapy within 2 weeks of start of study treatment.
  4. * Active autoimmune disease
  5. * Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state
  6. * Inadequate pulmonary function per Investigator assessment.
  7. * Uncontrolled brain or other central nervous system (CNS) metastases.
  8. * History of documented congestive heart failure (New York Heart Association \[NYHA\] class III - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias

Contacts and Locations

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85724-5024
United States
Highlands Oncology
Springdale, Arkansas, 72762
United States
City of Hope Medical Center
Duarte, California, 91010
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
United States
University of Miami
Miami, Florida, 33136
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Imugene Limited

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 Date2022-05-17
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-05-17
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • oncolytic virus

Additional Relevant MeSH Terms

  • Solid Tumor
  • Solid Carcinoma
  • Solid Tumor, Adult
  • Metastatic Cancer
  • Advanced Solid Tumor
  • Cholangiocarcinoma
  • Bile Duct Cancer