Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02045602
Eligibility Criteria:
Inclusion Criteria:
* 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
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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02045602
Study Brief:
Protocol Section:
NCT02045602