Trials / Completed
CompletedNCT02730312
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients With CD123-Expressing Hematologic Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Xencor, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.
Conditions
- Acute Myelogenous Leukemia
- B-cell Acute Lymphoblastic Leukemia
- Blastic Plasmacytoid Dendritic Cell Neoplasm
- Chronic Myeloid Leukemia, Blast Crisis
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | XmAb14045 | Administered IV weekly up to 8 weeks, with or without step-up dosing |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
- First posted
- 2016-04-06
- Last updated
- 2022-03-08
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02730312. Inclusion in this directory is not an endorsement.