Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and tolerability of VCN-01 either administered alone or in combination with Abraxane®/Gemcitabine, and to determine the recommended phase II dose of VCN-01 alone or in combination 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

• 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