Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9829 · 1 trial · 1 indication
DLTs are dose-limiting toxicities as defined in the study protocol.
Frequency, severity and relationship to study drug of AEs and SAEs
Incidence of AEs/SAEs and PK data
| Arm | Type | Description |
|---|---|---|
| Module 1: Dose Escalation | EXPERIMENTAL | Ascending dose level cohorts of AZD9829 in AML and MDS participants. |
| Module 1: Dose Optimization | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| AZD9829 | DRUG | AZD9829 will be administered by IV infusion |
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 h...
AZD9829 is an investigational small molecule being studied for the treatment of CD123-positive hematological malignancies. It is being developed by AstraZeneca PLC (ticker AZN) and is in Phase 1 clinical development. The study enrolled adults with these blood cancers across multiple countries.
AZD9829 targets CD123, a marker expressed on certain hematological malignancy cells. The Phase 1 trial specifically enrolled patients with CD123-positive disease, indicating a biomarker-selected approach. This targeted mechanism is intended to focus the drug's activity on CD123-expressing cancer cells.
AZD9829 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical trial evaluating AZD9829 in CD123-positive hematological malignancies.
AZD9829 is in Phase 1 clinical development. The single registered trial, NCT06179511, has been completed. AZD9829 is investigational and has not been approved by the FDA or any regulatory authority for any indication.
AZD9829 has been evaluated in one Phase 1 clinical trial, NCT06179511, titled Study of AZD9829 in CD123+ Hematological Malignancies. The trial enrolled 56 adults and has been completed. It was conducted in the United States, Australia, China, Germany, Italy, Japan, South Korea, Spain, Taiwan, and the United Kingdom.