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 as SC injection at the priming dose determined in Part 1, on Day 1, and at a target dose, based on the emergent safety data, on Day 8. |
| 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 for B-cell malignancies and autoimmune conditions including systemic lupus erythematosus, idiopathic inflammatory myopathies, and rheumatoid arthritis. It is currently in Phase 1 clinical development.
AZD5492 is a T cell-engaging antibody that targets CD20, a protein found on B cells. By engaging T cells to attack CD20-positive cells, it aims to deplete B cells involved in disease.
AZD5492 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.
AZD5492 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are currently recruiting participants.
AZD5492 is being studied in two Phase 1 trials. NCT06542250 evaluates it in relapsed/refractory B-cell malignancies with 174 participants. NCT06916806 investigates it in systemic lupus erythematosus, idiopathic inflammatory myopathies, and rheumatoid arthritis with 72 participants.
AZD5492 is a T cell-engaging antibody that targets CD20, meaning it binds to CD20 on B cells and engages T cells to destroy them. This mechanism is being studied for its potential in treating B-cell malignancies and autoimmune diseases.