Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8359 · 1 trial · 1 indication
Number of participants with AEs, AESIs, SAEs, including AEs leading to discontinuation of study intervention and clinically significant alterations from baseline in laboratory parameters, vital signs, ECGs and physical examination results
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness
Number of participants with a PSA50 response
| Arm | Type | Description |
|---|---|---|
| Module 1 - Part A (Dose Escalation) | EXPERIMENTAL | - |
| Module 2 - Part A (Dose Escalation) | EXPERIMENTAL | - |
| Module 1/2 - Part B1 (Dose Expansion) | EXPERIMENTAL | - |
| Module 1/2 - Part B2 (Dose Expansion) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZD8359 | DRUG | AZD8359 Monotherapy Administration route 1 |
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate or neuroendocrine differentiated prostate cancer * Surgically or medically castrated with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) * PSA value at screening should be ≥ 1ng/mL * Evidence of disease...
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AZD8359 is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is currently in Phase 1 clinical development, with a first-in-human trial evaluating its safety and efficacy in participants with this condition.
AZD8359 is a STEAP2 T-cell engager (TCE), meaning it is designed to target the STEAP2 protein, which is expressed on prostate cancer cells, and engage T-cells to attack those cells. This mechanism is being evaluated in the ongoing Phase 1 trial.
AZD8359 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial for this drug in metastatic prostate cancer.
AZD8359 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is currently being studied in a first-in-human trial for metastatic prostate cancer.
AZD8359 is being evaluated in a Phase 1 clinical trial with the identifier NCT07529717, titled 'First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer.' This trial is currently recruiting participants with metastatic prostate cancer in the United States, Australia, and South Korea.
Yes, AZD8359 is a STEAP2 T-cell engager (TCE), a type of small molecule designed to link T-cells to STEAP2-expressing prostate cancer cells. This mechanism is the focus of its ongoing Phase 1 clinical trial in metastatic prostate cancer.