Actively Recruiting
Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2026-05-14
33
Participants Needed
6
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have disease progression despite anti-cancer treatment and are not eligible for other treatments or their lesions are not suitable for palliative external beam radiation therapy.
- Participants must have a confirmed cancer diagnosis with multiple metastatic bone lesions and at least one painful osteoblastic tumor causing a pain score of 4 or higher on the NRS11 pain scale.
- Bone metastases must be confirmed by a 99mTc-diphosphonate bone scan within 60 days before dosing, with at least one lesion osteoblastic.
- Participants must have adequate kidney function with creatinine clearance of 30 mL/min or higher.
- Participants must have hematologic function with platelet count above 100,000 cells/mm3 and absolute neutrophil count above 1000 cells/mm3.
- Hemoglobin level must be 8 g/dL or higher.
- Liver function must meet specified limits for bilirubin and liver enzymes.
- Participants must have a life expectancy of at least 16 weeks from the date of study drug administration.
- Karnofsky performance status must be greater than 60% at screening.
You will not qualify if you...
- Pregnant or breastfeeding participants are excluded.
- Participants who have received maximum radiation to the spinal cord, untreated bone fractures, spinal cord compression, unstable spine, or imminent long bone fracture.
- Participants with widespread bone metastases showing diffuse intense skeletal uptake with absent or faint kidney/bladder activity on bone scan (Superscan pattern).
- Those with impending or suspected spinal cord compression or at high risk for it.
- Participants with neurogenic pain or significant pain from soft tissue lesions that might interfere with pain assessment.
- Participants requiring surgery during the trial that would need pain medication.
- Clinically significant illness or trauma within 2 weeks before receiving the study drug.
- History of unstable angina or new angina within 3 months before screening.
- History of myocardial infarction within 3 months before screening.
- Uncontrolled severe cardiac arrhythmias or history of severe arrhythmia.
- Congestive heart failure of New York Heart Association Class 2 or higher.
- Abnormal ECG findings including prolonged QT interval.
- Inability to complete necessary imaging exams.
- Presence of other conditions increasing risk or interfering with study participation.
- Active infections such as HIV, HPV, Hepatitis A, B, or C.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Biogenix Molecular, LLC, CIRA Health
Miami, Florida, United States, 33165
Actively Recruiting
2
NovaCure
Miami, Florida, United States, 33176
Actively Recruiting
3
Houston Metro Urology
Houston, Texas, United States, 77027
Actively Recruiting
4
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
5
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, United States, 77042
Actively Recruiting
6
University of Texas Medical Branch at Galveston (UTMB)
Houston, Texas, United States, 77555
Actively Recruiting
Research Team
S
Sahar Khan
CONTACT
S
Sapna Shah, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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