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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01397708 | Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma | PHASE1 | COMPLETED | 26 | — | — | Aug 1, 2011 | Sep 1, 2014 | Oct 29, 2025 | 9 | United States |
Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs). Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.
| Arm | Type | Description |
|---|---|---|
| INXN-1001 in combination with INXN-2001 | EXPERIMENTAL | Intratumoral injections of INXN-2001 (Ad-RTS-hIL-12) at a constant dose in combination with inter-cohort escalating doses of INXN-1001 (activator ligand). |
| Name | Type | Description |
|---|---|---|
| INXN-2001 | BIOLOGICAL | * approximately 1.0 x 1012 viral particles (vp) per injection * one intratumoral injection of INXN-2001 per study cycle * maximum of 6 study cycles |
| INXN-1001 | DRUG | * 4 dose cohorts (5mg/day, 20mg/day, 100mg/day, and 160mg/day) * 7 oral daily doses of INXN-1001 per study cycle * maximum of 6 study cycles * 1 Expansion cohort at a single dose level at or below MTD (160mg/day) |
Inclusion Criteria: * Males or females of all races ≥ 18 years of age, who have provided written informed consent prior to completing any study specific procedure. * Unresectable Stage III or Stage IV melanoma arising from any site other than ocular melanoma. * A minimum of 2 accessible nonvisceral...