Clinical trial · Interventional
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
NCT02749331CI-TRIAL-00083213RADNETactive not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AdVince | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AdVince
- description
- Dose escalation, minimum 3 patients per dose in Phase I. Dose levels: 1. 10 000 000 000 virus particles 2. 100 000 000 000 virus particles 3. 300 000 000 000 virus particles 4. 1000 000 000 000 virus particles Maximum tolerated dose will be confirmed by 12 additional patients treated at this dose level in Phase IIa.
- interventionNames
- Drug: AdVince
Primary outcomes (1)
- measure
- Number of Adverse Events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03
- timeFrame
- From screening visit and through study completion, an average time of 18 months.
- description
- AEs probably or possibly related to the study drug or local injuries caused by the administration procedure. If possible identify dose limiting toxicity (DLT), i.e. grade 4 toxicity of any duration or grade 3 toxicity lasting more than 7 days, excluding flu-like symptoms, according to CTCAE v4.03.Clinically significant changes in laboratory parameters (haematology, blood coagulation, liver function, biochemistry and kidney function) and vital signs (body temperature, heart rate, blood pressure, respiratory rate and consciousness according to Reaction Level Scale from 1985 (RLS-85).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject´s written informed consent 2. Histologically and radiologically confirmed progressive neuroendocrine carcinoma of gastrointestinal, pancreatic or bronchial origin with multiple liver metastases. Progression in Clinical symptoms and tumor growth verified over the last 6 months on CT or MRI 3. Cancer that is not considered resectable for potential cure or tumor reduction 4. Patent portal vein and adequate liver perfusion 5. Liver dominant disease with involvement of \<60% of liver parenchyma 6. Karnofsky performance status of \>=70% 7. Life expectancy of \>=6 months 8. \>=18 years of age 9. Must use a reliable method of contraception if sexually active and of reproductive potential 10. Plasma creatinine \<105 ug/ml 11. Aspartate transaminase (AST), Alanine transaminase (ALT) and Alkaline Phosphatase (ALP) \<3.0-fold upper limit of normal 12. Total bilirubin \<2.0-fold upper limit of normal 13. Prothrombin time (PT)/International Normalized Ratio (INR) \<2.0 and Prothromboplastin time (PTT) within normal limits 14. Neutrophils \>1500/ml, hemoglobin \>100 g/L, platelets \>100 000/ml 15. Patients with functioning NET should have cover by somatostatin analog Exclusion Criteria: 1. Known chronic liver dysfunction Before the development of metastatic cancer (e.g. cirrhosis, chronic hepatitis) 2. Active infection, including documented HIV and hepatitis C 3. Any viral syndrome diagnosed within the previous 2 weeks 4. Chemotherapy within the previous 4 weeks Before the first treatment 5. Radiotherapy to the target tumor site within the last 24 weeks from the baseline CT scan 6. Concomitant malignancy 7. Pregnant or lactating females 8. Prior participation in any research protocol that involved administration of adenovirus vectors 9. Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease 10. Continuing treatment with any other cancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.