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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07020117 | A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors | PHASE1 | RECRUITING | 150 | — | — | Aug 22, 2025 | Jun 1, 2032 | Apr 21, 2026 | 9 | United States |
• Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT in Part 1, will be reported by dose level.
• An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.
• Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST 1.1, by tumor types.
| Arm | Type | Description |
|---|---|---|
| [225Ac]Ac-AKY-1189 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [225Ac]Ac-AKY-1189 (therapeutic) | DRUG | \[225Ac\]Ac-AKY-1189 Injection |
| [64Cu]Cu-AKY-1189 (imaging) | DRUG | \[64Cu\]Cu-AKY-1189 Injection |
Inclusion Criteria: * Histologic or cytologic confirmation of locally advance or metastatic disease * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1 * ECOG Performance Status of 0 or 1 * Adequate end-organ function * Ability to give informed consent and comply...