DNX-2440 for Resectable Colorectal Liver Metastasis

Last updated: April 5, 2024
Sponsor: DNAtrix, Inc.
Overall Status: Suspended

Phase

1

Condition

Colon Cancer

Renal Cell Cancer

Neoplasm Metastasis

Treatment

DNX-2440

Clinical Study ID

NCT04714983
2440LM-002
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 gastrointestinalstromal tumor
  • Multiple (≥ 2) liver tumors
  • Candidate for curative-intent surgery
  • Stated willingness to comply with all study procedures and availability for theduration of the study.
  • Candidates eligible for targeted therapy, as per standard of care guidelines (andbased on mutational status as indicated), must have completed therapy
  • Preoperative chemotherapy is allowed

Exclusion

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 thestudy and for up to 6 months after injection with DNX-2440

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: DNX-2440
Phase: 1
Study Start date:
February 15, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • H. Lee Moffitt Cancer Center and Research Institute, Inc.

    Tampa, Florida 33612
    United States

    Site Not Available

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