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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06710756 | Lead-212 PSV359 Therapy for Patients With Solid Tumors | PHASE1 | RECRUITING | 112 | — | — | Apr 28, 2025 | May 28, 2032 | Jun 5, 2026 | 8 | United States |
Incidence and severity of treatment-related adverse events following a single administration of \[203Pb\]Pb-PSV359 is determined
Incidence and severity of treatment-related adverse events following a single and each repeated administration of \[212Pb\]Pb-PSV359 is determined
The recommended phase 2 dose as determined by cohort observations and review by the Safety Monitoring Committee
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | * Enrolled subjects are administered \[203Pb\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Approximately Four cohorts of \[212Pb\]Pb-PSV359 dose levels will be explored for determining Recommended Phase 2 Dose (RP2D). Study subjects will be assigned to cohorts sequentially. |
| Dose Expansion | EXPERIMENTAL | * Enrolled subjects are administered \[203Pb\]Pb-PSV359 (7mCi) for imaging FAP-expressing cancers. * Enrolled subjects are administered \[212Pb\]Pb-PSV359 (RP2D determined previously) for treatment of FAP-expressing cancers |
| Name | Type | Description |
|---|---|---|
| [203Pb]Pb-PSV359 | DRUG | \[203Pb\]Pb-PSV359 is administered by intravenous bolus injection for single-photon emission computed tomography imaging. |
| [212Pb]Pb-PSV359 | DRUG | \[212Pb\]Pb-PSV359 is administered by intravenous infusion for treatment of FAP expressing cancers. |
Inclusion Criteria: * Aged ≥ 18 years * Satisfactory organ function as determined by laboratory testing * Eastern Cooperative Oncology Group performance (ECOG) status of 0 to 1 * Life expectancy \> 3 months * Progressive disease despite standard therapy or for whom no standard therapy exists * Posi...