Locally Advanced Solid TumorsPhase 1NCT02045602
Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
A Phase 1 study testing VCN-01, Gemcitabine and Abraxane® in people with Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by Theriva Biologics SL at 5 sites in Spain.
Trial summary
The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Solid Tumors, Metastatic Solid Tumors, 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
- 42 participants
- Where
- 5 sitesSpain
- Study dates
- Jan 2014to Jan 2020
- 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
- Part I: Patients with histologically confirmed, locally advanced or metastatic solid tumors. Part II and Part III: Patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is Abraxane®/Gemcitabine (clinical standard of care)
- Life expectancy above 3 months
- Patients willing to comply with treatment follow-up
- 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 11Show fewer
- 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
- Adequate levels of neutralizing antibodies against adenovirus
- Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Vall d'Hebron
Barcelona, 08035
Institut Català d'Oncologia
L'Hospitalet de Llobregat, 08908
Centro Integral Oncológico Clara Campal
Madrid, 25080
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.
Read the detailed description
The study consists of three parts:
- Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone
- In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.
- In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.
- Being tested
- VCN-01, Gemcitabine, Abraxane®
- Keywords
- Cancer, Solid Tumors, Gemcitabine, Oncolytic virus, Metastatic, Pancreatic cancer
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms
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 |
|---|---|---|
| Part I: Dose Escalation, Single Agent | Experimental | Single intravenous injection of VCN-01 oncolytic adenovirus Receives: Genetic: VCN-01 |
| Part II: Dose Escalation, Combination | Experimental | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine Receives: Genetic: VCN-01; Drug: Gemcitabine; Drug: Abraxane® |
| Part III: Dose Escalation, Combination, "delayed" schedule | Experimental | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/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) 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 by analyzing viral genome copies in tumor biopsy
Measured: Day 8-10
Viral Pharmacokinetics
Determination of VCN-01 half-life by analyzing viral genome copies in blood
Measured: Up to 48 h
Viral Shedding
And at least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD)
Measured: Up to day 28
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 completionMay 2019
- Study completionJan 2020
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 Locally Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT02045602
- Sponsor's protocol ID
- P-VCNA-001
- Other IDs
- 2012-005555-16
- Status last verified
- Oct 2020
- First submitted
- 21 Jan 2014
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Carbonero R, Bazan-Peregrino M, Gil-Martin M, Alvarez R, Macarulla T, Riesco-Martinez MC, Verdaguer H, Guillen-Ponce C, Farrera-Sal M, Moreno R, Mato-Berciano A, Maliandi MV, Torres-Manjon S, Costa M, Del Pozo N, Martinez de Villarreal J, Real FX, Vidal N, Capella G, Alemany R, Blasi E, Blasco C, Cascallo M, Salazar R. Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors. J Immunother Cancer. 2022 Mar;10(3):e003255. doi: 10.1136/jitc-2021-003255.
PubMed 35338084
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. 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 Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02045602
- Acronym / sponsor ID
- P-VCNA-001
- Keywords
- Cancer, Solid Tumors, Gemcitabine, Oncolytic virus, Metastatic, Pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Theriva Biologics SLIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jan 2020 (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 VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination with Abraxane®/Gemcitabine.
Detailed description
The study consists of three parts:
- Part I is a dose escalation study to determine the safety and tolerability of a single intravenous injection of VCN-01 alone
- In Part II the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine.
- In Part III the safety and tolerability of the two highest VCN-01 tolerable doses from part I will be evaluated in combination with Abraxane®/Gemcitabine in a "delayed" schedule compared with Part II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I: Dose Escalation, Single Agent | Experimental | Genetic: VCN-01Single intravenous injection of VCN-01 oncolytic adenovirus |
| Part II: Dose Escalation, Combination | Experimental | Genetic: VCN-01, Drug: Gemcitabine, Drug: Abraxane®Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine |
| Part III: Dose Escalation, Combination, "delayed" schedule | Experimental | Genetic: VCN-01, Drug: Gemcitabine, Drug: Abraxane®Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/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
- Part I: Patients with histologically confirmed, locally advanced or metastatic solid tumors. Part II and Part III: Patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is Abraxane®/Gemcitabine (clinical standard of care)
- Life expectancy above 3 months
- Patients willing to comply with treatment follow-up
Key exclusion criteria (11 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 | Part I: Dose Escalation, Single Agent, Part II: Dose Escalation, Combination, Part III: Dose Escalation, Combination, "delayed" schedule |
| Gemcitabine1000 mg/m2 intravenous administration | Drug | Part II: Dose Escalation, Combination, Part III: Dose Escalation, Combination, "delayed" schedule |
| Abraxane®125 mg/m2 intravenous administration | Drug | Part II: Dose Escalation, Combination, Part III: Dose Escalation, Combination, "delayed" schedule |
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) 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 8-10
Viral Pharmacokinetics
Time frame: Up to 48 h
Viral Shedding
Time frame: Up to day 28
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 8 Oct 2020.
- Derived from this study: PubMed 35338084Garcia-Carbonero R, Bazan-Peregrino M, Gil-Martin M, Alvarez R, Macarulla T, Riesco-Martinez MC, Verdaguer H, Guillen-Ponce C, Farrera-Sal M, Moreno R, Mato-Berciano A, Maliandi MV, Torres-Manjon S, Costa M, Del Pozo N, Martinez de Villarreal J, Real FX, Vidal N, Capella G, Alemany R, Blasi E, Blasco C, Cascallo M, Salazar R. Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors. J Immunother Cancer. 2022 Mar;10(3):e003255. doi: 10.1136/jitc-2021-003255.
Related trials for Locally Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Cancer
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors
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.
5 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 Locally Advanced Solid Tumors and Metastatic Solid Tumors, run by Theriva Biologics SL at 5 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 11 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 NCT02045602, 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 8 Oct 2020.