Tampa, Florida 33612

  • Gastrointestinal Stromal Tumors

Purpose:

The purpose of this study is to test an experimental oncolytic adenovirus called DNX-2440 in patients with resectable multifocal (≥ 2 lesions) liver metastasis, who are scheduled to have curative-intent liver resection surgery. Up to 18 patients will receive two sequential intra-tumoral injections of DNX-2440 into a metastatic liver tumor prior to surgery for liver resection, to evaluate safety and biological endpoints across 3 dose levels (dose escalation). Upon conclusion of the dose-escalation phase, the selected safe and biologically appropriate dose will be administered using the same schema for an additional 12 patients with colorectal cancer liver metastasis (expansion cohort) using established biologic endpoints.


Criteria:

Key Inclusion Criteria: - Male or female aged ≥ 18 years at time of consent - Diagnosis of liver metastases from colorectal, breast, gastric, periampullary, melanoma, renal cell cancer, sarcoma, squamous cell carcinoma or gastrointestinal stromal tumor - Multiple (≥ 2) liver tumors - Candidate for curative-intent surgery - Stated willingness to comply with all study procedures and availability for the duration of the study. - Candidates eligible for targeted therapy, as per standard of care guidelines (and based on mutational status as indicated), must have completed therapy - Preoperative chemotherapy is allowed Key Exclusion Criteria: - Recurrence of liver metastasis - Diagnosis of neuroendocrine tumor liver metastasis - Liver metastasis treated with > 12 cycles of systemic chemotherapy - Condition that requires ongoing systemic immunosuppressive therapy - Evidence of inadequate organ function based on lab parameters - Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) or total bilirubin > 5x the upper limits of normal - Males or females who refuse to use a double-barrier form of birth control during the study and for up to 6 months after injection with DNX-2440


NCT ID:

NCT04714983


Primary Contact:

Study Director
Paul Chang, MPH
DNAtrix, Inc.

Paul Chang, MPH
Phone: 832-930-2401
Email: 2440LM-002study@DNAtrix.com


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States

Marjorie Brelsford
Phone: 813-745-3772
Email: Marjorie.Brelsford@moffitt.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

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