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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03311477 | A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors | PHASE1 | COMPLETED | 9 | — | — | Nov 6, 2017 | Mar 4, 2019 | Mar 14, 2019 | 2 | Japan |
AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or \< 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Maximum observed concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| ABBV-399 | EXPERIMENTAL | ABBV-399 via intravenous administration at escalating dose levels. |
| Name | Type | Description |
|---|---|---|
| ABBV-399 | DRUG | Intravenous infusion |
Inclusion Criteria: * Participant with histologically confirmed advanced solid tumor. * Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * Participant has an Eastern Cooperative Oncol...