Trials / Active Not Recruiting
Active Not RecruitingNCT02749331
Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy
Study of Recombinant Adenovirus (AdVince) in Patients With Neuroendocrine Tumors; Safety and Efficacy
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Uppsala University · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose.
Detailed description
An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose. Secondary objectives include to evaluate the anti-tumoral efficacy of AdVince infusions on metastatic neuroendocrine tumors, to determine the replication profile of AdVince and to determine the humoral (antibody) and cytokine-mediated immune response to AdVince. Minimum 12 and maximum 35 patients will be included, the number is based on the toxicity observed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AdVince | Virus solution for infusion in intrahepatic artery |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2025-08-01
- Completion
- 2025-12-01
- First posted
- 2016-04-22
- Last updated
- 2024-12-03
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT02749331. Inclusion in this directory is not an endorsement.