Study of IMLYGIC Injection to Treat Skin Tumors in Adults with Neurofibromatosis Type 1

What this Trial Is About

Researchers are investigating a new treatment approach for adults with neurofibromatosis Type I NF1 who have cutaneous neurofibromas cNFs, which are skin tumors causing disfigurement, pain, itching, or other concerns. This Phase 1 study focuses on evaluating the safety, feasibility, and possible effectiveness of IMLYGIC monotherapy in treating these skin tumors. The study is designed to provide important information for developing future treatments for NF1-related cNFs. Participants will receive IMLYGIC through injections directly into the tumors over a series of 28-day cycles. In the first cycle, the treatment is given on days 1 and 21, and in cycles 2 through 4, it is given on days 7 and 21, totaling up to eight treatments across four cycles. This intralesional administration aims to target the tumors locally. The study includes a safety run-in phase and monitors treatment tolerability and feasibility. During the study, participants will undergo medical history review, physical exams, vital sign checks, and lab tests to ensure organ function and overall health. Tumor response will be assessed by measuring lesions, taking photographs, and evaluating biopsies after cycles 2, 4, and at the end of treatment. Participants will be followed for 30 days after treatment to monitor outcomes and safety. The main goals include measuring how many participants complete all four treatment cycles and assessing whether the treatment causes serious side effects. The total study duration for each participant is approximately 16 weeks of treatment plus a follow-up period.

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