Clinical trial · Interventional
A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia
A Phase 1 Study of SGN-CD123A in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT02848248CI-TRIAL-00032900terminatedPhase 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)
The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.
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 |
|---|---|---|---|
| SGN-CD123A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGN-CD123A
- description
- SGN-CD123A every 3 weeks
- interventionNames
- Drug: SGN-CD123A
Primary outcomes (3)
- measure
- Type, incidence, severity, seriousness, and relatedness of adverse events
- timeFrame
- Through 1 month following last dose, or end-of-treatment visit whichever is later
- measure
- Type, incidence, and severity of laboratory abnormalities
- timeFrame
- Through 1 month following last dose, or end-of-treatment visit whichever is later
- measure
- Incidence of dose-limiting toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens * Patients may be eligible after only 1 previous regimen if in a high risk category * Adequate baseline renal and hepatic function * Eastern Cooperative Oncology Group Status of 0 or 1 * CD123-detectable leukemia Exclusion Criteria: * Cerebral/meningeal disease related to underlying malignancy * Promyelocytic leukemia * History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide \<50% predicted * Prior hematopoietic stem cell transplant * Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine) * Cardio or cerebral vascular event within 6 months
References
Publications (1)
- DERIVEDLi F, Sutherland MK, Yu C, Walter RB, Westendorf L, Valliere-Douglass J, Pan L, Cronkite A, Sussman D, Klussman K, Ulrich M, Anderson ME, Stone IJ, Zeng W, Jonas M, Lewis TS, Goswami M, Wang SA, Senter PD, Law CL, Feldman EJ, Benjamin DR. Characterization of SGN-CD123A, A Potent CD123-Directed Antibody-Drug Conjugate for Acute Myeloid Leukemia. Mol Cancer Ther. 2018 Feb;17(2):554-564. doi: 10.1158/1535-7163.MCT-17-0742. Epub 2017 Nov 15. PMID 29142066