Clinical trial NCT02045589: A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Adenocarcinoma
Metastatic Pancreatic Adenocarcinoma
Keywords: Cancer
Pancreatic adenocarcinoma
Locally advanced
Metastatic
Gemcitabine
Oncolytic virus
Abraxane®
Lead sponsor: Theriva Biologics SL
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Safety and Tolerability by means of Adverse Events (AEs) and laboratory data
timeFrame: At least 6 months
measure: 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
timeFrame: At least 6 months
Secondary outcomes:
measure: Presence of VCN-01 in tumor
timeFrame: Day 21-28
measure: Viral Pharmacokinetics
timeFrame: 48 h
measure: Viral Shedding
timeFrame: Up to day 71
measure: Neutralizing antibodies anti-VCN-01
timeFrame: 30 days after end of treatment phase
measure: Preliminary anti-tumor activity by Overall Response Rate (ORR)
timeFrame: CT or MRI scans every 8 weeks until disease progression
measure: Preliminary anti-tumor activity by Progression Free Survival (PFS)
timeFrame: CT or MRI scans every 8 weeks until disease progression
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Català d'Oncologia
state: Barcelona
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References:
citation: 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.