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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02955251 | A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors | PHASE1 | COMPLETED | 61 | — | — | Nov 18, 2016 | Oct 29, 2019 | Jul 20, 2020 | 15 | United States, Australia +2 |
If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). |
| Arm A, B, and C | EXPERIMENTAL | Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428. |
| Arm D | EXPERIMENTAL | Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab. |
| Arm 2 | EXPERIMENTAL | ABBV-428 plus nivolumab. |
| Name | Type | Description |
|---|---|---|
| ABBV-428 | DRUG | ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15. |
| Nivolumab | DRUG | Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules. |
Inclusion Criteria: * Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies. * Participants have adequate bone marrow, renal, hepatic and coagulation function. * For all dose ex...