Metastatic Pancreatic Adenocarcinoma, Pancreatic Adenocarcinoma
Conditions
Keywords
Cancer, Pancreatic adenocarcinoma, Locally advanced, Metastatic, Gemcitabine, Oncolytic virus, Abraxane®
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.
Interventions
Sponsors
Theriva Biologics SL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability by means of Adverse Events (AEs) and laboratory data | 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 | At least 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Shedding | Up to day 71 | At least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD) |
| Neutralizing antibodies anti-VCN-01 | 30 days after end of treatment phase | At least up to 6 months follow-up in patients at the MTD |
| Presence of VCN-01 in tumor | Day 21-28 | Determination of VCN-01 viral genome copies in tumor biopsy |
| Preliminary anti-tumor activity by Progression Free Survival (PFS) | CT or MRI scans every 8 weeks until disease progression | — |
| Preliminary anti-tumor activity by Overall Response Rate (ORR) | CT or MRI scans every 8 weeks until disease progression | — |
| Viral Pharmacokinetics | 48 h | Determination of VCN-01 half-life by analyzing viral genome copies in blood |
Countries
Spain
Outcome results
None listed