Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07529717 | First-in-Human Study to Evaluate AZD8359 STEAP2 TCE in Participants With Prostate Cancer | PHASE1 | RECRUITING | 42 | — | — | May 18, 2026 | Nov 17, 2027 | May 22, 2026 | 8 | United States, Australia +1 |
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...