Trials / Suspended
SuspendedNCT04714983
DNX-2440 for Resectable Colorectal Liver Metastasis
A Phase I Safety and Window-of-opportunity Study of Preoperative Intratumoral Injection of OX40-ligand Expressing Oncolytic Adenovirus (DNX-2440) in Patients With Resectable Liver Metastasis
- Status
- Suspended
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- DNAtrix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Liver Metastases
- Liver Metastasis Colon Cancer
- Colorectal Cancer
- Breast Cancer
- Gastric Cancer
- Periampullary Cancer
- Melanoma
- Renal Cell Cancer
- Sarcoma
- Squamous Cell Carcinoma
- Gastrointestinal Stromal Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DNX-2440 | DNX-2440 is a replication competent oncolytic adenovirus expressing human OX40 ligand. |
Timeline
- Start date
- 2021-02-15
- Primary completion
- 2026-07-31
- Completion
- 2026-12-31
- First posted
- 2021-01-20
- Last updated
- 2024-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04714983. Inclusion in this directory is not an endorsement.