Clinical trial · Interventional
Phase I Dose Escalation Study of Intravenous VCN-01 With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
A Phase I, Multicenter, Open-label, Dose Escalation Study of Intravenous Administration of VCN-01 Oncolytic Adenovirus With or Without Gemcitabine and Abraxane® in Patients With Advanced Solid Tumors
NCT02045602CI-TRIAL-00047574completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane® | Drug | Paclitaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| VCN-01 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part I: Dose Escalation, Single Agent
- description
- Single intravenous injection of VCN-01 oncolytic adenovirus
- interventionNames
- Genetic: VCN-01
- type
- EXPERIMENTAL
- label
- Part II: Dose Escalation, Combination
- description
- Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine
- interventionNames
- Genetic: VCN-01
- Drug: Gemcitabine
- Drug: Abraxane®
- type
- EXPERIMENTAL
- label
- Part III: Dose Escalation, Combination, "delayed" schedule
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGarcia-Carbonero R, Bazan-Peregrino M, Gil-Martin M, Alvarez R, Macarulla T, Riesco-Martinez MC, Verdaguer H, Guillen-Ponce C, Farrera-Sal M, Moreno R, Mato-Berciano A, Maliandi MV, Torres-Manjon S, Costa M, Del Pozo N, Martinez de Villarreal J, Real FX, Vidal N, Capella G, Alemany R, Blasi E, Blasco C, Cascallo M, Salazar R. Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors. J Immunother Cancer. 2022 Mar;10(3):e003255. doi: 10.1136/jitc-2021-003255. PMID 35338084