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RECRUITING
NCT07197645
PHASE1

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

Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-10-21

Completion Date

2027-07-05

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

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.

Locations (3)

Houston Metro Urology

Houston, Texas, United States

Oncology Consultants

Houston, Texas, United States

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, United States