Clinical trial · Interventional
A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML
A Phase 1b Dose-escalation Study of SGN-CD33A in Combination With Standard-of-care for Patients With Newly Diagnosed 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) by itself (monotherapy) or in combination with other standard treatments. The main purpose of this study is to find the best dose and schedule for SGN-CD33A when given in combination with standard induction treatment, in combination with standard consolidation treatment, or by itself for maintenance treatment. This 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-leukemic activity of the study treatment will be assessed.
Conditions
Conditions (2)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| High dose cytarabine for consolidation | Drug | — | UNRESOLVED |
| SGN-CD33A | Drug | — | UNRESOLVED |
| Standard dose cytarabine for induction | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Induction with SGN-CD33A
- description
- 7+3 (Standard dose cytarabine for induction and daunorubicin) + SGN-CD33A
- interventionNames
- Drug: Standard dose cytarabine for induction
- Drug: SGN-CD33A
- Drug: Daunorubicin
- type
- EXPERIMENTAL
- label
- Consolidation with SGN-CD33A
- description
- High dose cytarabine for consolidation + SGN-CD33A (28-day cycles)
- interventionNames
- Drug: SGN-CD33A
- Drug: High dose cytarabine for consolidation
- type
- EXPERIMENTAL
- label
- SGN-CD33A Maintenance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia) * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function * Central venous access * Part specific requirements: eligible to receive induction; achieved CR/CRi with standard induction and eligible to receive consolidation; in CR with documented blood count recovery for maintenance Exclusion Criteria: * Previous treatment for MDS or MPN for dose escalation cohorts * Inadequate lung function * Inadequate heart function
References
Publications (0)
Data not yet available