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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06879041 | A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer | PHASE1 | RECRUITING | 136 | — | — | Mar 10, 2025 | Apr 16, 2029 | May 12, 2026 | 16 | United States, Australia +1 |
| Arm | Type | Description |
|---|---|---|
| Part A: Cohort A1: AZD2287 (Hot only) | EXPERIMENTAL | Participants will receive AZD2287. If eligible for treatment, will receive dose level (DL)1 of AZD2284. |
| Part A: Cohort A2: AZD2275 + AZD2287 (Cold +Hot) | EXPERIMENTAL | Participants will receive DL1 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284. |
| Part A: Cohort A3: AZD2275 + AZD2287 (Cold +Hot) | EXPERIMENTAL | Participants will receive DL2 of AZD2275 followed by AZD2287. If eligible for treatment, will receive DL1 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL1: AZD2284 | EXPERIMENTAL | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL1 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL2: AZD2284 | EXPERIMENTAL | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL2 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL3: AZD2284 | EXPERIMENTAL | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL3 of AZD2284. |
| Part B (Actinium-225 Dose Escalation): DL4: AZD2284 | EXPERIMENTAL | Participants will receive AZD2287 (± AZD2275 as determined in Part A). If eligible for treatment, will receive DL4 of AZD2284. |
| Part B: Cohort E1 | EXPERIMENTAL | Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level. |
| Part B: Cohort E2 | EXPERIMENTAL | Participants will receive dose of AZD2284 determined by the earlier results. Expansion cohort may be opened to further characterize the safety and efficacy of the dose level. |
| Name | Type | Description |
|---|---|---|
| AZD2287 | DRUG | Participants will receive AZD2287 |
| AZD2275 | DRUG | Participants will receive AZD2275 |
| AZD2284 | DRUG | Participants will receive AZD2284 |
Main Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Histologically confirmed diagnosis of adenocarcinoma of the prostate without strong clinical suspicion of majority neuroendocrine differentiation. * Must have had prior bilateral orchiectomy and/or ...