{"entity":{"id":"nct04954001","kind":"trial","name":"Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1","aka":[],"tldr":"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.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT04954001","url":"https://clinicaltrials.gov/study/NCT04954001"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["shanghai-fosun-pharmaceutical-industrial-development"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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.","participation":[{"nct":"NCT04954001","source":"https://clinicaltrials.gov/study/NCT04954001","fetchedAt":"2026-10-07T16:53:31.375Z","studySha256":"e305a64bb6ab38d9f769fd40d96fcef28e2b1d83e6a1f382df0bf530fcb85c95","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2024-11-12","leadSponsor":"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","collaboratorCount":0,"minimumAge":"2 Years","maximumAge":"70 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":160,"enrolmentType":"ESTIMATED","siteCount":14,"recruitingSiteCount":0,"countries":["China","Spain","United States"]}],"started":"2021-03-26","startedType":"actual","enrolled":160,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04954001/","neighbours":{"cancer":[{"id":"childhood-cancers","kind":"cancer","name":"Childhood cancers (all types)","route":"/cancers/childhood-cancers/"}],"company":[{"id":"shanghai-fosun-pharmaceutical-industrial-development","kind":"company","name":"Shanghai Fosun Pharmaceutical Industrial Development","route":"/companies/shanghai-fosun-pharmaceutical-industrial-development/"}]}}