Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Theriva Biologics SL
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.
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
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 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
Concurrent malignant hematologic or solid disease
Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
