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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07197645 | Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain | PHASE1 | RECRUITING | 33 | — | — | Oct 21, 2025 | Jul 5, 2027 | May 14, 2026 | 6 | United States |
Incidence and severity of hematologic and non-hematologic toxicities, graded per CTCAE v5.0, assessed through 6 weeks post-dose.
| Arm | Type | Description |
|---|---|---|
| Part A - Cohort 1 | EXPERIMENTAL | Dose Escalation |
| Name | Type | Description |
|---|---|---|
| 153Sm-DOTMP | DRUG | TLX090-Tx will be administered as a single ascending intravenous dose to participants with at least 1 confirmed painful osteoblastic bone tumor that exhibits avid uptake as shown by 99mTcdiphosphonate bone scans undertaken within 60 days of dosing. |
Inclusion Criteria: * Participants have had disease progression while on anti-cancer treatment, and are not eligible for the treatments, or their lesions are not amenable to palliative EBRT. * Participants must have a histologically confirmed diagnosis of malignancy at any time prior to their parti...