At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed colorectal adenocarcinoma with liver-dominant metastases (CT-measurable, <50% total liver involvement)
- ✓Failed conventional chemotherapy for metastatic disease (e.g., no longer responding to 5-FU/leucovorin with irinotecan or oxaliplatin with or without one monoclonal antibody)
- ✓Candidate for additional chemotherapy and/or experimental anti-cancer therapy
- ✓Seropositive for HSV-1
- ✕Dominant extrahepatic disease, including cerebral metastases, significant malignant ascites, or symptomatic/critical extrahepatic metastases
- ✕Seronegative for HSV-1
- ✕Active viral hepatitis (hepatitis A, B, or C) or HIV infection
- ✕Acute HSV infection requiring systemic antiviral therapy or history of serious HSV infection (ocular, encephalitic, etc.)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II, Open-label Study to Evaluate the Safety and Anti-tumor Effects of NV1020 Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-line Chemotherapy, in Patients With Colorectal Adenocarcinoma Metastatic to the Liver
In Brief
A Phase 2 clinical trial evaluating NV1020 for Colorectal Cancer and Liver Neoplasms. Completed, enrolled 32 participants across 5 sites.
Detailed Summary
This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver. Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy. Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.
Study Details
Timeline
Interventions
NV1020 dose levels: 3x10\^6, 1x10\^7, 3x10\^7, and 1x10\^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks