Trial Profile

A Phase I, unicentric, open and dose escalation clinical trial to evaluate the safety and the activity of the oncolytic adenovirus VCN-01 in patients with refractory retinoblastoma

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 15 Oct 2025

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At a glance

Drugs Zabilugene almadenorepvec (Primary) ; Zabilugene almadenorepvec (Primary)
Indications Retinoblastoma
Focus Adverse reactions

27 Aug 2024 Status changed from active, no longer recruiting to completed.
13 Aug 2024 According to Theriva Biologics media release, the results form this trial were determined to be positive by the study Monitoring Committee. Discussions with key opinion leaders worldwide, as well as with regulatory agencies, are ongoing to refine our retinoblastoma clinical strategy.
31 Jul 2024 According to Theriva Biologics media release, company announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma.

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