AzTrials
AzTrials

Neuroendocrine TumorsPhase 1/2RADNETNCT02749331

Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy

A Phase 1/2 study testing AdVince in people with Neuroendocrine Tumors, run by Uppsala University at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
AdVince
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteSweden
Study dates
Mar 2016to Dec 2025
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject´s written informed consent
  • 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
  • Cancer that is not considered resectable for potential cure or tumor reduction
  • Patent portal vein and adequate liver perfusion
  • Liver dominant disease with involvement of <60% of liver parenchyma
  • Karnofsky performance status of >=70%
Show all 15Show fewer
  • Life expectancy of >=6 months
  • >=18 years of age
  • Must use a reliable method of contraception if sexually active and of reproductive potential
  • Plasma creatinine <105 ug/ml
  • Aspartate transaminase (AST), Alanine transaminase (ALT) and Alkaline Phosphatase (ALP) <3.0-fold upper limit of normal
  • Total bilirubin <2.0-fold upper limit of normal
  • Prothrombin time (PT)/International Normalized Ratio (INR) <2.0 and Prothromboplastin time (PTT) within normal limits
  • Neutrophils >1500/ml, hemoglobin >100 g/L, platelets >100 000/ml
  • Patients with functioning NET should have cover by somatostatin analog

Who cannot join

  • Known chronic liver dysfunction Before the development of metastatic cancer (e.g. cirrhosis, chronic hepatitis)
  • Active infection, including documented HIV and hepatitis C
  • Any viral syndrome diagnosed within the previous 2 weeks
  • Chemotherapy 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
  • Concomitant malignancy
Show all 10Show fewer
  • Pregnant or lactating females
  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Endocrine Oncology Clinic, Uppsala University Hospital

    Uppsala, 752 37

Other trials in Sweden

About this study

Official title: Study of Recombinant Adenovirus (AdVince) in Patients With Neuroendocrine Tumors; Safety and Efficacy

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.

Read the 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.

Being tested
AdVince
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdVinceDrug

    Also called Ad5PeptideTransductionDomain(PTD)(CgA-E1AmiR122)

    Virus solution for infusion in intrahepatic artery

Study groups in NCT02749331
Study groupRoleWhat they receive
AdVinceExperimentalDose 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.
Receives: Drug: AdVince

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03

    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).

    Measured: From screening visit and through study completion, an average time of 18 months.

Secondary outcomes (12)

  1. Change in tumor size

    Computer tomography (CT) and/or positron emission tomography (PET) with magnetic resonance imaging (MRI). Assessment based on Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST (mRECIST).

    Measured: Measured within 4 weeks before first treatment and after 80 +/-14 days (evaluation visit 1)

  2. Change in tumor size

    Computer tomography (CT) and/or positron emission tomography (PET) with magnetic resonance imaging (MRI). Assessment based on Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST (mRECIST).

    Measured: Measured within 4 weeks before first treatment and after 214 +/- 14 days (evaluation visit 2)

  3. Change in tumor metabolic activity

    Change in hormone levels including chromogranin- A (CgA), chromogranin-B (CgB), neuron specific enolase (NSE) and specific hormones.

    Measured: Baseline value within 24 hrs before first treatment and after 80 +/- 14 days(evaluation visit 1)

  4. Change in tumor metabolic activity

    Change in hormone levels including chromogranin- A (CgA), chromogranin-B (CgB), neuron specific enolase (NSE) and specific hormones.

    Measured: Baseline value within 24 hrs before first treatment and after 214 +/- 14 days (evaluation visit 2)

  5. Progression-free survival (PFS)

    Number of patients with progression-free survival (PFS).

    Measured: Twelve weeks after 80 days from first treatment (4 treatment cycles) or the corresponding time.

  6. Change in replication profile of AdVince

    Replication profile determined by quantification of adenovirus genomic copies in patient´s blood by quantitative real-time polymerase chain reaction (QRT-PCR).

    Measured: Before and 4hrs after each treatment cycle up to a time period of 214 days.

  7. Change in replication profile of AdVince

    Replication profile determined by quantification of adenovirus genomic copies in patient´s blood by quantitative real-time polymerase chain reaction (QRT-PCR).

    Measured: Before and 24hrs after each treatment up to a time period of 214 days.

  8. Change in replication profile of AdVince

    Replication profile determined by quantification of adenovirus genomic copies in patient´s blood by quantitative real-time polymerase chain reaction (QRT-PCR).

    Measured: Before and 72hrs after each treatment cycle up to a time period of 214 days.

  9. Change in the humoral immune response to AdVince

    Detection of anti-adenovirus neutralizing antibodies against adenovirus.

    Measured: At baseline, after 8+2 days, after 50 +/- 7days, optional after 124 +/- 7days and 184 +/- 7 days.

  10. Change in the cytokine-mediated immune response

    Measure from patient´s plasma.

    Measured: At baseline and at 4hrs following each treatment up to a time period of 214 days.

  11. Change in the cytokine-mediated immune response

    Measure from patient´s plasma.

    Measured: At baseline and at 24hrs following each treatment up to a time period of 214 days.

  12. Change in the cytokine-mediated immune response

    Measured from patient´s plasma.

    Measured: At baseline and at 72hrs following each treatment up to a time period of 214 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionAug 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749331
Sponsor's protocol ID
VIRUSNET201401
Other IDs
2014-000614-64, 2014
Acronym
RADNET
Status last verified
Nov 2024
First submitted
11 Mar 2016
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AdVince in people with Neuroendocrine Tumors, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (AE) according to Common Terminology Criteria for Adverse Events (CTCAE) v 4.03 (time frame: From screening visit and through study completion, an average time of 18 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02749331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in