Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07102394 | Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1 | PHASE1 | RECRUITING | 10 | — | — | Feb 1, 2026 | Dec 31, 2027 | May 8, 2026 | 1 | United States |
Feasibility is defined as ≥80% of participants receiving 4 treatments
Tolerability is defined as no participants have a DLT or SAE
| Arm | Type | Description |
|---|---|---|
| IMLYGIC | EXPERIMENTAL | 28-day treatment cycle will be defined as intralesional administration of IMLYGIC administered on Days 1 and 21 of each cycle for 4 cycles (8 treatments). |
| Name | Type | Description |
|---|---|---|
| Imlygic | DRUG | intralesional administration of IMLYGIC administered on Days 1 and 21 of each cycle for 4 cycles (8 treatments). |
Inclusion Criteria: * Males or females age ≥ 18 years who meet the NIH clinical criteria for the diagnosis of NF1 * Must have ≥8 measureable cNFs. Histologic confirmation of tumor is not necessary in the presence of consistent clinical findings or confirmed genetic testing. A Measurable cNF is defi...