Trials / Completed
CompletedNCT03082209
A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies
An Open-Label, Phase 1, First-In-Human Study of TRAIL Receptor Agonist ABBV-621 in Subjects With Previously-Treated Solid Tumors and Hematologic Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD), and evaluate the safety, efficacy, and pharmacokinetic (PK) profile of ABBV-621 for participants with previously-treated solid tumors or hematologic malignancies. Only chemotherapy combination (ABBV-621 + FOLFIRI) enrolling participants with RAS-mutant CRC who have received one prior line of therapy is open for enrollment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABBV-621 | Intravenous (IV) |
| DRUG | Venetoclax | tablet, oral |
| DRUG | Bevacizumab | IV infusion |
| DRUG | FOLFIRI | IV infusion |
Timeline
- Start date
- 2017-03-20
- Primary completion
- 2022-01-21
- Completion
- 2022-01-21
- First posted
- 2017-03-17
- Last updated
- 2022-12-09
Locations
19 sites across 4 countries: United States, Japan, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03082209. Inclusion in this directory is not an endorsement.