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

NCT04954001 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-11-12

No results posted yet for this study

Summary

FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib. FCN-159 is an orally available and highly potent selective inhibitor of MEK1/2, which is expected to be a targeted therapy for the treatment of advanced solid tumors and neurofibromatosis type 1.

Conditions

  • Neurofibromatosis 1
  • Plexiform Neurofibroma
  • NF1

Interventions

DRUG

FCN-159

FCN-159 is administered orally in once daily schedule for 28 days a cycle.

Sponsors & Collaborators

  • Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2025-02-28
Completion
2025-03-30
FDA Drug
Yes

Countries

  • United States
  • China
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954001 on ClinicalTrials.gov