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Keep this study
Lead
Theriva Biologics SL
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be 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
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 with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency
Clareo Health | A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer
