Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5492 · 2 trials · 4 indications
Number and percentage of participants with AEs, AESIs, and SAEs
Number and percentage of participants with AEs related to IMP as assessed by the investigator
Number and percentage of participants with DLTs (dose-limiting toxicities) as defined in the study protocol.
Number and percentage of participants with SAEs leading to death.
Number and percentage of participants with AEs according ASTCT, IEC-HS, and CTCAE grades.
Number and percentage of participants with treatment-related vital signs abnormalities.
Number and percentage of participants with treatment-related clinical laboratory abnormalities.
Number and percentage of participants with abnormal ECG.
DLTs are dose-limiting toxicities as defined in the study protocol.
Incidence and severity of AEs, AESIs, and SAEs
SAEs/AEs leading to discontinuation of AZD5492.
| Arm | Type | Description |
|---|---|---|
| Part 1: Single Ascending Dose with AZD5492 | EXPERIMENTAL | Participants will receive AZD5492 at an assigned dose as subcutaneous (SC) injection on Day 1. |
| Part 2: Step-Up Dosing with AZD5492 | EXPERIMENTAL | Participants will receive AZD5492 by SC as either: * Part 2a (sSUD): a priming dose on Day 1 followed by a target dose on Day 8; or * Part 2b (dSUD): a priming dose on Day 1, a second priming dose on Day 8, and a target dose on Day 15. |
| Module 1: AZD5492 Monotherapy | EXPERIMENTAL | AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies. |
| Name | Type | Description |
|---|---|---|
| AZD5492 | DRUG | IMP: subcutaneous. |
Inclusion Criteria: 1. Participant must be 18 to 70 years of age inclusive, at the time of signing the informed consent. 2. Diagnosis of SLE: 1. Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE 2. Positive for one or more of: anti-nuclear antibodies (titre ≥ 1...
AZD5492 is an investigational small molecule being developed by AstraZeneca PLC for B-cell malignancies and systemic lupus erythematosus. It is in Phase 1 clinical development and has not been approved by any regulatory agency. The program includes studies in autoimmune and inflammatory conditions as well as blood cancers.
AZD5492 is being studied for B-cell malignancies and systemic lupus erythematosus, with additional Phase 1 research in idiopathic inflammatory myopathies and rheumatoid arthritis. It remains investigational and is not approved for any indication. All current use is within clinical trials evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics.
AZD5492 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is running the Phase 1 program for the asset across multiple countries, including the United States, Canada, China, France, Germany, Japan, Spain, and the United Kingdom.
AZD5492 is in Phase 1 clinical development. Two Phase 1 trials are currently recruiting, one in B-cell malignancies and one in systemic lupus erythematosus, idiopathic inflammatory myopathies, and rheumatoid arthritis. No Phase 2 or later studies have been initiated, and the drug is not FDA approved.
AZD5492 is being evaluated in two recruiting Phase 1 trials. NCT06542250 tests the drug in relapsed or refractory B-cell malignancies with planned enrollment of 174 participants. NCT06916806 studies it in systemic lupus erythematosus, idiopathic inflammatory myopathies, and rheumatoid arthritis with planned enrollment of 72 participants.
Yes, the AZD5492 clinical program uses biomarker selection. The Phase 1 study in B-cell malignancies, NCT06542250, is described as targeting CD20, and the trials enroll adults 18 years and older without healthy volunteers. Both active studies are open-label and uncontrolled, with no randomization or blinding.