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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07630961 | Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors | PHASE1 | NOT YET_RECRUITING | 66 | — | — | Jun 15, 2026 | Jan 14, 2028 | Jun 5, 2026 | - | — |
Imaging properties of 68Ga-DFC413 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUV values 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).
Agreement between target lesions and normal organs from 68Ga-DFC413 and 68Ga-NNS309 PET imaging will be assessed using summary statistics of SUV and SUVr.
| Arm | Type | Description |
|---|---|---|
| Part 1: Imaging Characterization | EXPERIMENTAL | Single dose of 68Ga-DFC413 |
| Part 2: Comparative Assessment | EXPERIMENTAL | Single dose of 68Ga-DFC413 followed by 68Ga-NNS309; or single dose of 68Ga-NNS309 followed by 68Ga-DFC413 |
| Name | Type | Description |
|---|---|---|
| 68Ga-DFC413 | DRUG | Radioimaging agent |
| 68Ga-NNS309 | DRUG | Radioimaging agent |
Inclusion Criteria: Patients eligible for inclusion in this study must meet all of the following criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Age ≥ 18 years old. 3. ECOG performance status ≤ 2. 4. Patients with one of the following indications (rega...