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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07311993 | Phase 1 Study of CLR 125 in Triple Negative Breast Cancer | PHASE1 | RECRUITING | 60 | — | — | Dec 5, 2025 | Jul 1, 2029 | Jun 3, 2026 | 4 | United States |
Identify the recommended Phase 2 dose and regimen of CLR 125 in advanced TNBC patients
Adverse Events are graded per NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Dosimetry Phase | OTHER | Iopofosine I 131 (CLR 131) will be administered at 10 mCi on day 1 for approximately 15 patients for imaging purposes. |
| Treatment Phase: CLR 125 Arm 1 | EXPERIMENTAL | CLR 125 administered at 65 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 4 cycles. |
| Treatment Phase: CLR 125 Arm 2 | EXPERIMENTAL | CLR 125 will be administered at 125 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 3 cycles. |
| Treatment Phase: CLR 125 Arm 3 | EXPERIMENTAL | CLR 125 will be administered at 190 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 2 cycles. |
| Name | Type | Description |
|---|---|---|
| Iopofosine I 131 | DRUG | Investigational radiopharmaceutical product intended for IV administration. |
| CLR 125 | DRUG | Investigational radiopharmaceutical product intended for IV administration. |
Inclusion Criteria: * Unequivocal TNBC histology \[ER and PR less than 10% each and HER-2 negative\]. * Patients that have progressed after at least one prior standard therapeutic regimen given alone or in combination (including, but not limited, to: chemotherapy, immunotherapy, sacituzumab govitec...