Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
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
2 other identifiers
interventional
42
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2014
Longer than P75 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 21, 2014
CompletedFirst Posted
Study publicly available on registry
January 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedOctober 8, 2020
October 1, 2020
5.3 years
January 21, 2014
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
At least 6 months
Recommended Phase 2 Dose (RP2D) by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities
At least 6 months
Secondary Outcomes (6)
Presence of VCN-01 in tumor
Day 8-10
Viral Pharmacokinetics
Up to 48 h
Viral Shedding
Up to day 28
Neutralizing antibodies anti-VCN-01
30 days after end of treatment phase
Preliminary anti-tumor activity by Overall Response Rate (ORR)
CT or MRI scans every 8 weeks until disease progression
- +1 more secondary outcomes
Study Arms (3)
Part I: Dose Escalation, Single Agent
EXPERIMENTALSingle intravenous injection of VCN-01 oncolytic adenovirus
Part II: Dose Escalation, Combination
EXPERIMENTALSingle intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine
Part III: Dose Escalation, Combination, "delayed" schedule
EXPERIMENTALSingle intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine
Interventions
Genetically modified human adenovirus encoding human PH20 hyaluronidase
1000 mg/m2 intravenous administration
125 mg/m2 intravenous administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Chronic immunosuppressive therapy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Institut Català d'Oncologia
L'Hospitalet de Llobregat, 08908, Spain
Centro Integral Oncológico Clara Campal
Madrid, 25080, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Publications (1)
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.
PMID: 35338084DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2014
First Posted
January 27, 2014
Study Start
January 1, 2014
Primary Completion
May 1, 2019
Study Completion
January 1, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10