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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06229366 | [Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 142 | — | — | Apr 3, 2024 | Dec 1, 2032 | Dec 22, 2025 | 7 | Canada |
Phase Ia: Incidence of dose limiting toxicities (DLTs)
Phase 1b: Incidence and severity of treatment emergent adverse events (TEAEs)
Phase Ia: Incidence and severity of treatment emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| OmHSPC | EXPERIMENTAL | Patients with prostate cancer and biochemical recurrence after definitive surgery or radiation therapy, with 1-5 PSMA-positive lesions, who have not yet initiated lifelong hormone therapy. |
| mCRPC | EXPERIMENTAL | Patients with PSMA-positive mCRPC who have prior treatment with at least one APRI and received taxane chemotherapy (or ineligible/refused); and received a maximum of 3 prior systemic therapy regimens in the mCRPC setting. |
| Name | Type | Description |
|---|---|---|
| [Ac-225]-PSMA-62 (mCRPC) | DRUG | Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week cycle for up to 4 cycles. Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 6-week or 4-week cycle, for a total of 4 cycles. |
| [Ac-225]-PSMA-62 (OmHSPC) | DRUG | Phase Ia: Administered intravenously per dose escalation scheme. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle for up to 2 cycles. Phase Ib: Administered intravenously at MTD or one dose level below MTD. Patients will receive a single dose of \[Ac-225\]-PSMA-62 on Day 1 of each 8-week cycle, for a total of 2 cycles. |
Inclusion Criteria: 1. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate 2. ECOG performance status 0 to 1 3. Criteria specific for patients with mCRPC: 1. Previously received an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy...