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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03696771 | Study to Determine Safety and Dose of NJH395 in Non-breast HER2+ Advanced Cancer | PHASE1 | COMPLETED | 18 | — | — | Dec 27, 2018 | Oct 19, 2020 | Feb 4, 2022 | 4 | United States, Italy +2 |
The time frame will expand to 42 days for the second part of the study
| Arm | Type | Description |
|---|---|---|
| NJH395 | EXPERIMENTAL | Includes non-breast HER2-positive advanced malignancies |
| Name | Type | Description |
|---|---|---|
| NJH395 | DRUG | Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent |
Key Inclusion Criteria: * Patient must have known histologically or cytologically confirmed and documented HER2-positive solid tumor excluding patients with breast cancer * Advanced/metastatic cancer with measurable disease as determined by RECIST v.1.1 who have progressed or are intolerant to all ...