OncoMatch/Clinical Trials/NCT07102394
Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1
Is NCT07102394 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Imlygic for nf1.
Treatment: Imlygic — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: IMLYGIC
Previous treatment with IMLYGIC
Cannot have received: Granulocyte-macrophage colony-stimulating factor (GM-CSF)
treatment with Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Cannot have received: MEK inhibitor
Exception: current therapy or within 6 months prior to first dose
Currently receiving therapy with a Mitogen-Activated Protein Kinase (MEK) inhibitor or treated with a MEK inhibitor in the 6 months prior to the first dose of study treatment.
Cannot have received: anti-herpetic drug (acyclovir, valacyclovir, famciclovir)
Exception: other than intermittent topical use
Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir, valacyclovir, famciclovir, any other antiviral medications), other than intermittent topical use
Cannot have received: anti-herpetic treatment
Exception: within last 4 weeks prior to trial participation
Any anti-herpetic treatment within the last 4 weeks prior to trial participation
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500 cells/µL; Platelets ≥ 100 x 10^3/µL; Hemoglobin ≥ 9.5 g/dL; Serum albumin ≥ 2.8 g/dL
Kidney function
Calculated creatinine clearance at Screening ≥ 60 mL/min (by Cockcroft-Gault formula) OR a normal serum creatinine
Liver function
Alanine aminotransferase (ALT) ≤ 2x upper limit of institutional norm; Total bilirubin value of ≤1.5 x Upper Limit of Normal (ULN) (isolated bilirubin ≥1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Adequate organ and bone marrow and other organ function as defined by the following Screening laboratory values: 1. Absolute neutrophil count ≥ 1,500 cells/µL; 2. Platelets ≥ 100 x 103/µL; 3. Hemoglobin ≥ 9.5 g/dL; 4. Serum albumin ≥ 2.8 g/dL; 5. Calculated creatinine clearance at Screening ≥ 60 mL/min (by Cockcroft-Gault formula) OR a normal serum creatinine. 6. Alanine aminotransferase (ALT) ≤ 2x upper limit of institutional norm 7. Total bilirubin value of ≤1.5 x Upper Limit of Normal (ULN) (isolated bilirubin ≥1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins University · Baltimore, Maryland
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