NCT07197645

Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain

A Phase 1 Pharmacokinetic, Dosimetry, Safety, and Dose Optimization Study for a Single Dose of TLX090-Tx (153SmDOTMP) to Treat Metastatic Bone Pain

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, 2-part early phase study designed to evaluate the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of TLX090-Tx in patients with painful bone metastases.

Conditions

• Bone Pain
• Metastatic Bone Tumor
• Bone Metastases in Subjects With Advanced Cancer

Interventions

Type	Name	Description
DRUG	153Sm-DOTMP	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.

Timeline

• Start date: 2025-10-21
• Primary completion: 2027-04-26
• Completion: 2027-07-05
• First posted: 2025-09-29
• Last updated: 2026-01-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study