Trial Profile

A registrational Phase II/III trial of VCN-01 in pediatric patients with advanced retinoblastoma

Status: Planning

Phase of Trial: Phase II/III

Latest Information Update: 14 Jan 2026

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At a glance

29 Dec 2025 According to a Theriva Biologics media release, interactions with the EMA and FDA are planned in 2026 to seek advice on a potential Phase 2/3 trial of VCN-01 in retinoblastoma, a challenging pediatric cancer for which VCN-01 has received Rare Pediatric Disease designation.
07 May 2024 According to a Theriva Biologics media release, results of phase 1 trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma will help inform the planned Phase 2 trial design.
30 Mar 2023 According to a Theriva Biologics media release, the company plans to hold a pre-IND meeting with the FDA (H2 2023) to discuss the clinical development and potential registration pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma.

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