BridgeMD
Treatment of neuroendocrine neoplasms with genetically modified adenovirus
EU CTIS ID: 2024-517654-10-00
What this study is testing
The primary objective of this study is to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic NENs and if possible determination of maximum tolerated dose (MTD).
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject's written informed consent
- ≥ 18 years of age
- Must use a reliable method of contraception if sexually active and of reproductive potential
- Plasma creatinine < 105 µg/ml
- AST, ALT < 5.0-fold upper limit of normal
- Total bilirubin < 3.0-fold upper limit of normal
You likely can't join if
- Known chronic liver dysfunction before the development of metastatic cancer (e.g., cirrhosis, chronic hepatitis)
- Prior participation in any research protocol that involved administration of adenovirus vectors
- Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease
- Continuing treatment with any other cancer therapy
- Active infection, including documented HIV and hepatitis C
- Any viral syndrome diagnosed within the previous 2 weeks
See the full eligibility criteria
- Subject's written informed consent
- ≥ 18 years of age
- Must use a reliable method of contraception if sexually active and of reproductive potential
- Plasma creatinine < 105 µg/ml
- AST, ALT < 5.0-fold upper limit of normal
- Total bilirubin < 3.0-fold upper limit of normal
- PT/INR < 2.0 and PTT within normal limits
- Neutrophils > 1,500/µl, haemoglobin > 100 g/L, platelets > 100,000/µl
- Patients with functioning NEN should have cover by somatostatin analog
- Histologically confirmed NEN of gastrointestinal, pancreatic or bronchial origin
- Disease progression verified over the last 6 months on CT or MRI using criteria employed in standard practice at the local hospital
- Disease that is not considered resectable for potential cure or tumor reduction
- Standard anti-cancer therapy exhausted according to the European Society of Medical Oncology (ESMO) guidelines for GEP-NETs and according to the European Neuroendocrine Tumor Society (ENETS) guidelines for lung carcinoids
- Adequate liver perfusion ensured e.g. by patent portal vein, patent hepatic veins
- Liver dominant disease with involvement of < 60% of liver parenchyma
- Karnofsky performance status of ≥70%
- Life expectancy of ≥ 6 months
- Known chronic liver dysfunction before the development of metastatic cancer (e.g., cirrhosis, chronic hepatitis)
- Prior participation in any research protocol that involved administration of adenovirus vectors
- Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease
- Continuing treatment with any other cancer therapy
- Active infection, including documented HIV and hepatitis C
- Any viral syndrome diagnosed within the previous 2 weeks
- Systemic anti-cancer therapy (except for somatostatin analogues) within the previous 4 weeks before the first treatment
- Radiotherapy to the target tumor site within the last 24 weeks from the baseline CT scan
- Evidence of clinically significant immunosuppression such as primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
- Requirement of treatment with corticosteroids (prednisone >10 mg/day or equivalent)
- Concomitant malignancy
- Pregnant or lactating females
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.