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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07117214 | A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers | PHASE1 | NOT YET_RECRUITING | 36 | — | — | Aug 20, 2025 | Jan 26, 2027 | Aug 12, 2025 | - | — |
Imaging properties of FKL480 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUVmean and SUVmax will be calculated and reported with summary statistics.
SUVr will be calculated by dividing the SUV of the lesions by the SUV of the different organs in order to identify the reference organ with the lowest uptake and the respective SUVr (i.e. using SUVmean or SUVmax).
| Arm | Type | Description |
|---|---|---|
| Advanced breast cancer | EXPERIMENTAL | Patients will receive FKL480 (\[68Ga\]Ga-DWJ155) |
| Advanced NSCLC | EXPERIMENTAL | Patients will receive FKL480 (\[68Ga\]Ga-DWJ155) |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga-DWJ155 | DRUG | Radioligand imaging agent |
Inclusion Criteria: * Age ≥ 18 years old * Patients with histologically or cytologically confirmed and documented HR+/HER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR...