RecruitingPhase 1NCT07197645

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

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Enrollment

33 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 153Sm-DOTMP for people with bone metastases in subjects with advanced cancer, bone pain, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG153Sm-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.