Clinical trial · Interventional
Study of AZD9829 in CD123+ Hematological Malignancies
A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients With CD123-Positive Hematological Malignancies
NCT06179511CI-TRIAL-00116452completedPhase 1 / Phase 2ClinicalTrials.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 a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.
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 |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD9829 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Module 1: Dose Escalation
- description
- Ascending dose level cohorts of AZD9829 in AML and MDS participants.
- interventionNames
- Drug: AZD9829
- type
- EXPERIMENTAL
- label
- Module 1: Dose Optimization
- description
- Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants, based on the data collected during dose escalation, dose optimization and backfill.
- interventionNames
- Drug: AZD9829
Primary outcomes (3)
- measure
- Frequency of dose limiting toxicities (DLTs).
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age; * CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory; * R/R AML (except APL); * R/R HR-MDS with ≥5% bone marrow blast at time of inclusion; * Had at least 1 prior line of therapy at currents histology, and have no available treatment options; * ECOG performance status of ≤ 2. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active CNS leukemia; * Previous treatment with any CD123 targeting therapy; * Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy; * Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829; * History of other malignancy(with certain exceptions); * Active and uncontrolled infections; * Unresolved AEs ≥2 Grade, from prior therapies. The above is a summary, other exclusion criteria details may apply .
References
Publications (0)
Data not yet available
No reference posted for this study.