Pancreatic AdenocarcinomaPhase 1NCT02045589
A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer
A Phase 1 study testing VCN-01, Gemcitabine and Abraxane® in people with Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, run by Theriva Biologics SL at 3 sites in Spain.
Trial summary
The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- VCN-01, Gemcitabine and Abraxane®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2014to Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female patients aged 18 years or over
- Patients must provide written informed consent
- Life expectancy above 3 months
- Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment
- Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered.
- ECOG Performance status 0 or 1
- Adequate baseline organ function (hematologic, liver, renal and nutritional)
- Use a reliable method of contraception in fertile men and women
Who cannot join
- Active infection or other serious illness or autoimmune disease
- Treatment with live attenuated vaccines in the last three weeks
- Known chronic liver disease (liver cirrhosis, chronic hepatitis)
- Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
- Viral syndrome diagnosed during the two weeks before inclusion
- Chronic immunosuppressive therapy
Show all 10Show fewer
- Known concurrent malignant hematologic or solid disease
- Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
- Patients receiving full-dose anticoagulant / antiplatelet therapy
- Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Institut Català d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
Centro Integral Oncológico Clara Campal
Madrid, 25080
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: A Phase I, Multicenter, Open-label, Dose Escalation Study of Intratumoral Injections of VCN-01 Oncolytic Adenovirus With Intravenous Gemcitabine and Abraxane® in Advanced Pancreatic Cancer
The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.
Read the detailed description
Investigational treatment is a dose-escalation regimen consisting of three VCN-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous Abraxane® and gemcitabine.
- Being tested
- VCN-01, Gemcitabine, Abraxane®
- Keywords
- Cancer, Pancreatic adenocarcinoma, Locally advanced, Metastatic, Gemcitabine, Oncolytic virus, Abraxane®
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCN-01Genetic
Genetically modified human adenovirus encoding human PH20 hyaluronidase
GemcitabineDrug
1000 mg/m2 intravenous administration
Abraxane®Drug
125 mg/m2 intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation, Combination | Experimental | Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine. Receives: Genetic: VCN-01; Drug: Gemcitabine; Drug: Abraxane® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
Measured: At least 6 months
Recommended Phase 2 Dose (RP2D) of VCN-01 in combination with Gemcitabine and Abraxane® by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
Measured: At least 6 months
Secondary outcomes (6)
Presence of VCN-01 in tumor
Determination of VCN-01 viral genome copies in tumor biopsy
Measured: Day 21-28
Viral Pharmacokinetics
Determination of VCN-01 half-life by analyzing viral genome copies in blood
Measured: 48 h
Viral Shedding
At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)
Measured: Up to day 71
Neutralizing antibodies anti-VCN-01
At least up to 6 months follow-up in patients at the MTD
Measured: 30 days after end of treatment phase
Preliminary anti-tumor activity by Overall Response Rate (ORR)
Measured: CT or MRI scans every 8 weeks until disease progression
Preliminary anti-tumor activity by Progression Free Survival (PFS)
Measured: CT or MRI scans every 8 weeks until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2016
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theriva Biologics SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045589
- Sponsor's protocol ID
- P-VCNA-002
- Other IDs
- 2012-005556-42
- Status last verified
- Sep 2018
- First submitted
- 21 Jan 2014
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bazan-Peregrino M, Garcia-Carbonero R, Laquente B, Alvarez R, Mato-Berciano A, Gimenez-Alejandre M, Morgado S, Rodriguez-Garcia A, Maliandi MV, Riesco MC, Moreno R, Ginesta MM, Perez-Carreras M, Gornals JB, Prados S, Perea S, Capella G, Alemany R, Salazar R, Blasi E, Blasco C, Cascallo M, Hidalgo M. VCN-01 disrupts pancreatic cancer stroma and exerts antitumor effects. J Immunother Cancer. 2021 Nov;9(11):e003254. doi: 10.1136/jitc-2021-003254.
PubMed 35149591
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label, Dose Escalation Study of Intratumoral Injections of VCN-01 Oncolytic Adenovirus With Intravenous Gemcitabine and Abraxane® in Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02045589
- Acronym / sponsor ID
- P-VCNA-002
- Keywords
- Cancer, Pancreatic adenocarcinoma, Locally advanced, Metastatic, Gemcitabine, Oncolytic virus, Abraxane®
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Theriva Biologics SLIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.
Detailed description
Investigational treatment is a dose-escalation regimen consisting of three VCN-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous Abraxane® and gemcitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation, Combination | Experimental | Genetic: VCN-01, Drug: Gemcitabine, Drug: Abraxane®Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male/Female patients aged 18 years or over
- Patients must provide written informed consent
- Life expectancy above 3 months
- Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment
- Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered.
Key exclusion criteria (10 listed)
- Active infection or other serious illness or autoimmune disease
- Treatment with live attenuated vaccines in the last three weeks
- Known chronic liver disease (liver cirrhosis, chronic hepatitis)
- Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
- Viral syndrome diagnosed during the two weeks before inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VCN-01Genetically modified human adenovirus encoding human PH20 hyaluronidase | Genetic | Dose Escalation, Combination |
| Gemcitabine1000 mg/m2 intravenous administration | Drug | Dose Escalation, Combination |
| Abraxane®125 mg/m2 intravenous administration | Drug | Dose Escalation, Combination |
Primary outcome
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
Time frame: At least 6 months
Recommended Phase 2 Dose (RP2D) of VCN-01 in combination with Gemcitabine and Abraxane® by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
Time frame: At least 6 months
6 secondary outcomes
Presence of VCN-01 in tumor
Time frame: Day 21-28
Viral Pharmacokinetics
Time frame: 48 h
Viral Shedding
Time frame: Up to day 71
Neutralizing antibodies anti-VCN-01
Time frame: 30 days after end of treatment phase
Preliminary anti-tumor activity by Overall Response Rate (ORR)
Time frame: CT or MRI scans every 8 weeks until disease progression
Preliminary anti-tumor activity by Progression Free Survival (PFS)
Time frame: CT or MRI scans every 8 weeks until disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Derived from this study: PubMed 35149591Bazan-Peregrino M, Garcia-Carbonero R, Laquente B, Alvarez R, Mato-Berciano A, Gimenez-Alejandre M, Morgado S, Rodriguez-Garcia A, Maliandi MV, Riesco MC, Moreno R, Ginesta MM, Perez-Carreras M, Gornals JB, Prados S, Perea S, Capella G, Alemany R, Salazar R, Blasi E, Blasco C, Cascallo M, Hidalgo M. VCN-01 disrupts pancreatic cancer stroma and exerts antitumor effects. J Immunother Cancer. 2021 Nov;9(11):e003254. doi: 10.1136/jitc-2021-003254.
Related trials for Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VCN-01, Gemcitabine and Abraxane® in people with Pancreatic Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, run by Theriva Biologics SL at 3 sites in Spain.
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 8 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: finished, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data (time frame: At least 6 months). The study lists 2 primary outcomes in all. 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 NCT02045589, which also lists 1 linked publication.
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 1 Oct 2018.