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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005555-16 | EudraCT Number |
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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.
The study consists of three parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: Dose Escalation, Single Agent | Experimental | Single intravenous injection of VCN-01 oncolytic adenovirus |
|
| Part II: Dose Escalation, Combination | Experimental | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine |
|
| Part III: Dose Escalation, Combination, "delayed" schedule | Experimental | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCN-01 | Genetic | Genetically modified human adenovirus encoding human PH20 hyaluronidase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability by means of Adverse Events (AEs) and laboratory data | At least 6 months | |
| Recommended Phase 2 Dose (RP2D) by determination of highest feasible dose (MFD) and any Dose Limiting Toxicities | At least 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of VCN-01 in tumor | Determination of VCN-01 by analyzing viral genome copies in tumor biopsy | Day 8-10 |
| Viral Pharmacokinetics | Determination of VCN-01 half-life by analyzing viral genome copies in blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain | |||
| Institut Català d'Oncologia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35338084 | Derived | Garcia-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. |
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| Gemcitabine | Drug | 1000 mg/m2 intravenous administration |
|
| Abraxane® | Drug | 125 mg/m2 intravenous administration |
|
| Up to 48 h |
| Viral Shedding | And at least up to 6 months follow-up in patients at the Maximum Tolerated Dose (MTD) | Up to day 28 |
| Neutralizing antibodies anti-VCN-01 | At least up to 6 months follow-up in patients at the MTD | 30 days after end of treatment phase |
| Preliminary anti-tumor activity by Overall Response Rate (ORR) | CT or MRI scans every 8 weeks until disease progression |
| Preliminary anti-tumor activity by Progression Free Survival (PFS) | CT or MRI scans every 8 weeks until disease progression |
| L'Hospitalet de Llobregat |
| 08908 |
| Spain |
| Centro Integral Oncológico Clara Campal | Madrid | 25080 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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