Trials / Completed
CompletedNCT02955251
A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors
A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABBV-428 | ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15. |
| DRUG | Nivolumab | Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules. |
Timeline
- Start date
- 2016-11-18
- Primary completion
- 2019-10-29
- Completion
- 2019-10-29
- First posted
- 2016-11-04
- Last updated
- 2020-07-20
Locations
15 sites across 4 countries: United States, Australia, France, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02955251. Inclusion in this directory is not an endorsement.