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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06780670 | Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy | PHASE2 | RECRUITING | 443 | — | — | Feb 27, 2025 | Jul 19, 2033 | May 27, 2026 | 81 | United States, Australia +10 |
Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
Safety defined as the type, incidence and severity of AEs and SAEs, and deaths
Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure
Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
Percentage of participants who are alive or who are lost to follow-up at the time of analysis
| Arm | Type | Description |
|---|---|---|
| Phase II: AAA817 Dose B | EXPERIMENTAL | AAA817 will be given for a number of cycles; a cycle = 8 weeks |
| Phase III: Investigator's choice of SoC | ACTIVE_COMPARATOR | Participants will be given Standard of Care (SOC) treatment per Investigator's choice. |
| Phase II: AAA817 Dose A | EXPERIMENTAL | AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks |
| Phase III: Recommended Phase 3 Dose of AAA817 | EXPERIMENTAL | Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks |
| Name | Type | Description |
|---|---|---|
| Investigators choice of SoC | DRUG | The control treatment in Phase III is investigator's choice of SoC |
| AAA817 | DRUG | The investigational treatment is AAA817 |
Inclusion Criteria: ∙ * adults ≥ 18 years of age. * ECOG performance status of 0 to 2. * histopathological and/or cytological confirmation of adenocarcinoma of the prostate. * PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed, * castra...