Trials / Completed
CompletedNCT02674763
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- ImmunoGen, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive disease.
Detailed description
In the Dose Escalation Phase, patients will be assigned to one of three schedules. The MTD for all schedules will be determined from the assessment of Dose Limiting Toxicities (DLTs). The Dose Expansion Phase will consist of one cohort based on patients response to prior therapy according to the MTD selected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMGN779 |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2019-06-01
- Completion
- 2019-07-01
- First posted
- 2016-02-04
- Last updated
- 2019-09-04
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02674763. Inclusion in this directory is not an endorsement.