A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VCN Biosciences, S.L.
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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