Approval Probability
TA Base Rate
Adjusted LOA
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153Sm-DOTMP · 1 trial · 3 indications
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...
153Sm-DOTMP is an investigational small molecule being developed for the treatment of bone pain, specifically in patients with metastatic bone tumors and bone metastases from advanced cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
153Sm-DOTMP targets bone tissue. It is designed to deliver the radioisotope samarium-153 to areas of bone affected by metastatic disease, with the goal of providing long-lasting analgesia for cancerous end-stage bone pain.
153Sm-DOTMP is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker symbol TLX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with bone pain from metastatic cancer.
153Sm-DOTMP is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The ongoing Phase 1 trial is currently recruiting participants to assess the treatment in patients with bone pain due to metastatic disease.
153Sm-DOTMP is being studied in a Phase 1 clinical trial registered as NCT07197645, titled 'Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain.' This open-label, uncontrolled study is recruiting 33 participants in the United States with bone pain from metastatic bone tumors or advanced cancer.
153Sm-DOTMP is a specific formulation that incorporates the radioisotope samarium-153 (153Sm) chelated to DOTMP, a bone-seeking agent. While it contains samarium-153, it is a distinct investigational drug being developed by Telix Pharmaceuticals for the treatment of bone pain in metastatic cancer.