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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06267729 | Study of AZD0754 in Participants With Metastatic Prostate Cancer | PHASE1 | RECRUITING | 60 | — | — | Mar 12, 2024 | Nov 24, 2026 | Feb 23, 2026 | 15 | United States, Australia +1 |
Determine if treatment with AZD0754 is safe and tolerable through assessment of DLTs/DLT-like events, AEs, AESIs, SAEs, and changes from baseline in laboratory parameters, vital signs, and ECGs.
| Arm | Type | Description |
|---|---|---|
| AZD0754 | EXPERIMENTAL | AZD0754 monotherapy for treatment of participants with metastatic prostate cancer. |
| AZD2287 | EXPERIMENTAL | AZD2287 is a novel imaging agent for STEAP2 |
| Name | Type | Description |
|---|---|---|
| AZD0754 | BIOLOGICAL | Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce AZD0754. During AZD0754 production, subjects may receive bridging therapy for disease control. Upon successful generation of AZD0754 product, subjects will receive treatment with AZD0754 therapy. Study treatment will include lymphodepleting chemotherapy. After lymphodepleting chemotherapy AZD0754 is administered intravenously and patients will be required to stay at the hospital for a protocol specified monitoring period. |
| AZD2287 | BIOLOGICAL | This is an Optional arm of the study, which subjects will separately consent to if they would like to participate. Subjects will receive doses of a radioactive imaging agent called AZD2287 followed by SPECT/CT imaging scans at two time points. |
Inclusion Criteria: Age 1. Participant must be 18 years or older at the time of signing the informed consent form. Type of Participant and Disease Characteristics 2. Participants with: 1. A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroe...