# Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1

Source: https://onco.cc/trials/nct04954001/  
OnCo record `nct04954001` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of FCN-159 in childhood cancers, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., active and no longer recruiting.

## Summary

Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 is a phase 1/2 interventional study registered as NCT04954001 by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., with 160 participants enrolled, started 2021-03-26 and due to reach its primary completion in 2025-02-28. Interventions recorded: FCN-159.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04954001
- Phase: 1/2
- Setting: A Multi-center, Open-label, Single-arm Phase I Dose-escalation and Phase II Dose-expansion Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
- Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Enrolled: 160

## Sources

- ClinicalTrials.gov NCT04954001: https://clinicaltrials.gov/study/NCT04954001

## Connected records

- cancers: [Childhood cancers (all types)](https://onco.cc/cancers/childhood-cancers/)
- companies: [Shanghai Fosun Pharmaceutical Industrial Development](https://onco.cc/companies/shanghai-fosun-pharmaceutical-industrial-development/)

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JSON: https://onco.cc/api/v1/entities/nct04954001.json