drugset
drugset / Trial / NCT05997602

To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH

NCT05997602 ↗

Phase 2 Recruiting 56 enrolled Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a rare disease, single-arm, open-label,multi-center, non-randomized Phase 2 clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of FCN-159 monotherapy in pediatric patients with refractory/recurrent Langerhans cell histiocytosis (LCH).

Timeline

Start
2023-09-28
Primary completion
2025-05-14
Completion
2027-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Luvometinib Small molecule 5 mg/m2 Oral

Indications

Langerhans cell histiocytosis