Trials / Active Not Recruiting
Active Not RecruitingNCT03386513
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients With CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 179 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
Detailed description
IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMGN632 | CD123-targeted ADC |
Timeline
- Start date
- 2018-01-02
- Primary completion
- 2023-09-06
- Completion
- 2026-12-30
- First posted
- 2017-12-29
- Last updated
- 2024-12-16
Locations
28 sites across 6 countries: United States, France, Germany, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03386513. Inclusion in this directory is not an endorsement.