Clinical trial · Interventional
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
NCT02674763CI-TRIAL-00040411completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMGN779 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation Schedule A
- description
- IMGN779 administered on days 1 and 15 of a 28-day cycle
- interventionNames
- Drug: IMGN779
- type
- EXPERIMENTAL
- label
- Dose Escalation Schedule B
- description
- IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
- interventionNames
- Drug: IMGN779
- type
- EXPERIMENTAL
- label
- Dose Escalation Schedule C
- description
- IMGN779 administered on days 1 and 8 of a 21-day cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Dose Escalation: Patients with relapsed or refractory AML * Dose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable candidates for induction therapy Exclusion Criteria: * Dose Escalation: Acute Promyelocytic Leukemia * Any concurrent anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational agents (with the exception of hydroxyurea or leukapheresis for control of hyperleukocytosis) within 14 days or five half-lives of drugs, whichever is shorter, prior to Cycle 1 Day 1 * AML patients with known, active leptomeningeal/central nervous system (CNS) involvement * Prior treatment with IMGN779 * Women who are pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.