Status:
SUSPENDED
DNX-2440 for Resectable Colorectal Liver Metastasis
Lead Sponsor:
DNAtrix, Inc.
Collaborating Sponsors:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Liver Metastases
Liver Metastasis Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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-inte...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04714983
Start Date
February 15 2021
End Date
December 31 2026
Last Update
April 9 2024
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, United States, 33612