Symptoms and General Pathology

All Conditions

Neoplasms

Eye Diseases

Infections

Diseases and Abnormalities at or Before Birth

Rare Diseases

Recurrence

Retinoblastoma

Adenoviridae Infections

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Neuroepithelioma

Dose lower : 2E+9 viral particules/eye Dose medium: 2E+10 viral particules/eye Dose high: 2E+11 viral particules/eye

VCN-01

Jaume Catalá Mora, Dr

Phase I study, single site, open label with dose escalation, for evaluate safety and the oncolitic Adenovirus VCN-01 activity in patients with refractory retinoblastoma.

Phase I clinical trial, single-center, open-label, dose-escalation study, to evaluate the safety of the VCN-01 and, secondarily, its anti-tumoral activity. The trial sample consists of approximately 13 patients aged between 1 and 12 years old.

Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma

Phase I Study, Single Site, Open Label With Dose Escalation, for Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma

Anonymized individual data of participants will be shared with Authorities at the end of the Clinical development plan by the CTD (Common Technical Document). Results will be published in a scientific publication

Presence of VCN-01 in vitreous humor samples of enucleated eyes

The safety and tolerability of two intravitreal injections of VCN-01 will be determined with dose escalation until the maximum tolerated dose (MTD) is established based on the evaluation of adverse events and the observation of any dose-limiting toxicity (TLD).

Tumor response rate (ORR) to VCN-01 at 28 days post-administration.

Virus presence in blood samples, aqueous humor, ocular surface and nasal swabs, and its difference between the viral particles before and after the treatment to evaluate the excretion profile of the CNV-01.

The presence of neutralizing antibodies in blood samples in study patients to assess the immune response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma	NCT03284268	Retinoblastoma,...	VCN-01	1 Year - 12 Years	Fundació Sant Joan de Déu
Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma	NCT03284268	Retinoblastoma,...	VCN-01	1 Year - 12 Years	Fundació Sant Joan de Déu

Spots Global Cancer Trial Database for retinoblastoma, recurrent