Trials / Terminated
TerminatedNCT03224819
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 673 Administered as Short Term Intravenous Infusions in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
- Status
- Terminated
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the safety and tolerability of emerfetamab in adults with relapsed/refractory acute myeloid leukemia (AML) and to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose \[RP2D\]).
Detailed description
This is a first-in-human, open-label, phase 1, sequential dose escalation study. Emerfetamab will be evaluated as a short term intravenous (IV) infusion in adults with relapsed/refractory AML The study will consist of a dose escalation phase and a dose expansion phase. The study was terminated prior to the start of the expansion phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Emerfetamab | Administered by intravenous (IV) infusion. |
Timeline
- Start date
- 2017-09-07
- Primary completion
- 2020-12-28
- Completion
- 2020-12-28
- First posted
- 2017-07-21
- Last updated
- 2023-09-01
- Results posted
- 2023-09-01
Locations
7 sites across 3 countries: United States, Australia, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03224819. Inclusion in this directory is not an endorsement.