PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
NCT02730312 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2022-03-08
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
- BIOLOGICAL
-
XmAb14045
Administered IV weekly up to 8 weeks, with or without step-up dosing
Sponsors & Collaborators
-
ICON Clinical Research
collaborator INDUSTRY -
Xencor, Inc.
lead INDUSTRY
Principal Investigators
-
Raman Garcha, MD · Xencor, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2021-09-30
- Completion
- 2021-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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