Trial Profile

A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination With Chemotherapy in Participants With High-Risk Neuroblastoma

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 12 May 2026

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At a glance

24 Apr 2026 New trial record
15 Apr 2026 According to Renaissance Pharma media release, The programme builds on encouraging Phase II data evaluating Daretabart (hu1418K322A) as part of first-line therapy and in the post-consolidation setting for patients with HRNB.
15 Apr 2026 According to Renaissance Pharma media release, The company confirms it has received IND clearance from the FDA, enabling initiation of the SHINE Phase II/III clinical trial in relapse or refractory children with HRNB in the United States.

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