Trials / Completed
CompletedNCT03234712
A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)
A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABBV-321 | Intravenous infusion |
Timeline
- Start date
- 2017-10-10
- Primary completion
- 2021-04-14
- Completion
- 2021-04-14
- First posted
- 2017-07-31
- Last updated
- 2021-05-06
Locations
18 sites across 3 countries: United States, Australia, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03234712. Inclusion in this directory is not an endorsement.