Clinical trial · Interventional
A Safety Study of SGN-CD33A in AML Patients
A Phase 1 Trial of SGN-CD33A in Patients With CD33-positive Acute Myeloid Leukemia
- 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 study will examine the safety profile of vadastuximab talirine (SGN-CD33A) administered as a single agent and in combination with a hypomethylating agent (HMA). The main purpose of the study is to find the maximum tolerated dose (MTD, which is the highest dose that does not cause unacceptable side effects) of SGN-CD33A in patients with acute myeloid leukemia (AML). The MTD will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of SGN-CD33A. In addition, the pharmacokinetic profile and anti-leukemia activity of SGN-CD33A will be assessed.
Conditions
Conditions (3)
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 Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMA | Drug | — | UNRESOLVED |
| SGN-CD33A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SGN-CD33A + HMA
- description
- SGN-CD33A with hypomethylating agent
- interventionNames
- Drug: HMA
- Drug: SGN-CD33A
- type
- EXPERIMENTAL
- label
- SGN-CD33A Monotherapy
- description
- SGN-CD33A
- interventionNames
- Drug: SGN-CD33A
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- Through 1 month following last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Acute myeloid leukemia, positive for CD33 * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function * Central venous access * Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation and have experienced relapse of disease or declined treatment with high-dose induction/consolidation * Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients Exclusion Criteria: * Inadequate lung function * Prior allogeneic stem cell transplant, except for a specific cohort * High-dose chemotherapy within 4 weeks of study drug * Antileukemia treatment within 14 days of study drug (other than hydroxyurea or 6-mercaptopurine)
References
Publications (1)
- DERIVEDStein EM, Walter RB, Erba HP, Fathi AT, Advani AS, Lancet JE, Ravandi F, Kovacsovics T, DeAngelo DJ, Bixby D, Faderl S, Jillella AP, Ho PA, O'Meara MM, Zhao B, Biddle-Snead C, Stein AS. A phase 1 trial of vadastuximab talirine as monotherapy in patients with CD33-positive acute myeloid leukemia. Blood. 2018 Jan 25;131(4):387-396. doi: 10.1182/blood-2017-06-789800. Epub 2017 Dec 1. PMID 29196412