Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1

Fosun Pharma

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: NF1; Neurofibromatosis 1; Plexiform Neurofibroma

Treatments: Drug: Luvometinib Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024394

FCN-159-002-LT

Details and patient eligibility

About

FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1/2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study NCT04954001.This study is a 5-year long-term follow-up of the FCN-159-002 study, involving all enrolled patients to further assess safety, growth and development effects, and treatment efficacy.

Enrollment: 65 estimated patients

Sex: All

Ages: 2 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients from the pediatric cohort of the FCN-159-002 study. Willing to participate in the long-term follow-up study and capable of understanding and voluntarily signing the informed consent form.

Exclusion criteria

Any clinically significant condition that, in the investigator's judgment, may interfere with study participation or compliance with safety requirements.

Patients unable to comply with visit-related requirements.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

FCN-159

Experimental group

Description:

Study Drug: FCN-159 Dosing Regimen: FCN-159 to be administered once daily until disease progression or study completion, whichever occurs first

Treatment:

Drug: Luvometinib Tablets