DNX-2440 for Resectable Colorectal Liver Metastasis
Liver Metastases, Liver Metastasis Colon Cancer, Colorectal Cancer
About this trial
This is an interventional treatment trial for Liver Metastases
Eligibility 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
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Dose-level 1
Dose-level 2
Dose-level 3
The dose-level 1 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.
The dose-level 2 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.
The dose-level 3 arm will use a 3+3 design. A single dose of DNX-2440 will be delivered via intra-tumoral injection at Visit 1 and at Visit 3 (2 administrations in total) approximately 14 days apart.