DNX-2440 for Resectable Colorectal Liver Metastasis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    30
  • sponsor
    DNAtrix, Inc.
Updated on 21 July 2021
cancer
carcinoma
squamous cell carcinoma
metastasis
liver metastasis
chemotherapy regimen
cancer chemotherapy
targeted therapy
gastrointestinal stromal tumor
stromal tumor

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.

Details
Condition Skin Cancer, Breast Cancer Diagnosis, Gastric Carcinoma, Kidney Cancer, Liver Metastases, Stomach Cancer, soft tissue sarcomas, Advanced Malignancies, Renal Cancer, Renal Cell Cancer, breast carcinoma, Sarcoma (Pediatric), Solid Tumors, Colon Cancer Screening, squamous cell cancer, Rectal Disorders, Breast Cancer, Melanoma, melanoma, Soft Tissue Sarcoma, Malignant Melanoma, cancer, renal, Squamous Cell Carcinoma, Stomach Discomfort, Liver Metastasis Colon Cancer, Hepatic Metastases, Periampullary Adenocarcinoma, Rectal disorder, epidermoid carcinoma, Colon cancer; rectal cancer, Malignant Adenoma, Gastropathy, Carcinoma, gist, colorectal tumor, cancer, breast, cancer, colorectal, Renal Cell Carcinoma, sarcomas, colorectal cancers, gastric cancers, tumors, colorectal, Vulvar Dysplasia and Carcinoma, Sarcoma, Liver Metastasis, Metastatic Melanoma, Secondary Malignant Neoplasm of Liver, Squamous cell carcinoma, All Solid Tumors, Adenocarcinoma, colorectal neoplasm, skin cancer, Connective and Soft Tissue Neoplasm, gastrointestinal stromal tumors, gastrointestinal stromal tumor, Colorectal Cancer, Malignant neoplasm of kidney, Periampullary Cancer, Gastric Cancer
Treatment DNX-2440
Clinical Study IdentifierNCT04714983
SponsorDNAtrix, Inc.
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

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

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
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