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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03538028 | A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies | PHASE1 | COMPLETED | 22 | — | — | Jun 18, 2018 | Oct 7, 2020 | Oct 30, 2020 | 4 | United States |
TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
| Arm | Type | Description |
|---|---|---|
| INCAGN02385 | EXPERIMENTAL | Part 1: INCAGN02385 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation to determine the maximum tolerated dose or pharmacologically active dose. Part 2: INCAGN02385 administered Q2W or Q4W at the recommended dose(s) from Part 1. |
| Name | Type | Description |
|---|---|---|
| INCAGN02385 | BIOLOGICAL | INCAGN02385 administered as an intravenous infusion over 30 minutes. |
Inclusion Criteria: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Disease progression after treatment with available therapies that are known to confer clinical benefit, or intolerant to treatment, or refuse noncurative ...