Breast Cancer Clinical Trial

DNX-2440 for Resectable Colorectal Liver Metastasis

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT04714983

Recruitment Status:

Suspended

Sponsor:

DNAtrix, Inc.

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There is 1 Location for this study

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H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa Florida, 33612, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT04714983

Recruitment Status:

Suspended

Sponsor:


DNAtrix, Inc.

How clear is this clinincal trial information?

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