drugset / Trial / NCT07102394

Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1

NCT07102394

Phase 1 Recruiting 10 enrolled Johns Hopkins University Amgen · collab
NaSingle-groupOpen-labelTreatment

Summary

This study is designed to establish the foundation for a new therapy for neurofibromatosis Type I (NF1)-related cutaneous neurofibromas (cNFs) by assessing the feasibility and efficacy of IMLYGIC in adults with NF1 and cNFs who desire local treatment of their cNF due to disfigurement, progression, pain, itching or other concerns. This is a single institutional Phase 1 study with a safety run-in to assess the feasibility and efficacy of IMLYGIC monotherapy in NF1 patients with cNFs. Each 28-day treatment cycle will be defined as intralesional administration of IMLYGIC administered on day 1 and 21 of Cycle 1 and days 7 and 21 for Cycles 2-4 for up to 4 cycles.

Timeline

Start
2026-02-01
Primary completion
2026-12
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Talimogene Laherparepvec Other / unclassified Other