New radioactive drug aims to calm cancer bone pain
NCT ID NCT07197645
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests a single dose of TLX090-Tx, a radioactive drug, in 33 adults with advanced cancer that has spread to the bones and causes pain. The goal is to find a safe dose and see if it can reduce pain. Participants must have at least one painful bone spot and have tried other treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TLX090-Tx (153Sm-DOTMP)
- What this could lead to
- If it works, this could provide a new option to reduce severe bone pain in people with advanced cancer that has spread to the bones.
- What could go wrong
- This is a very early Phase 1 trial with only 33 people, so it is mainly checking safety and dosing. It may not reduce pain, and there could be side effects like low blood counts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 participation in this clinical trial with multiple metastatic bone lesions with at least 1 metastatic painful osteoblastic tumor that causes a minimum pain score of 4 on the NRS11. * Participants must have bone cancer in one or more skeletal locations as identified by a 99mTc-diphosphonate bone scan within 60 days of dosing. At least one lesion must be osteoblastic. If described as osteosclerotic, radiology confirmation that the lesion is osteoblastic is required. Adequate organ function, including: * Renal function, defined as a measured creatinine clearance (CrCl) ≥30 mL/min as per Cockroft Gault or based on radioisotope glomerular filtration rate (GFR). * Hematologic function, defined as a platelet count of \>100,000 cells/mm3 and an Absolute neutrophil count (ANC) of \>1000 cells/mm3. * Hemoglobin ≥8 g/dL. * Liver function: * Total bilirubin ≤1.5 × the upper limit of normal (ULN). * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 × ULN with participants with known liver metastases. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 × ULN with participants with Gilbert's Syndrome. * Life expectancy of at least 16 weeks from the date of study drug administration (Day 1). * Karnofsky performance status \>60%, assessed during the screening period prior to study drug administration. Exclusion Criteria: * Participants are pregnant or breastfeeding. * Participants who have received maximum tolerable radiation to the spinal cord, have untreated pathologic bone fracture, spinal cord compression, unstable spine, or imminent long bone fracture. * Participants with a bone scan pattern showing diffuse, intense skeletal uptake with absent or faint kidney / bladder activity, typically indicating widespread bone metastases or high bone turnover from metabolic or hematologic diseases (Superscan) pattern on Technetium 99-m bone scan scintigraphy - defined as diffusely increased skeletal uptake with absent or markedly reduced renal and soft tissue visualization - are excluded from the study. * Participants with impending or suspected or at high risk for spinal cord compression. * Participants with neurogenic pain or significant pain associated with soft tissue lesions or other pain that, in the opinion of the Investigator, might interfere with the assessment of pain relief for bone tumors. * Participants who require surgery over their trial period that would require pain medication or analgesia. * Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product. * History of unstable angina (defined as angina at rest) or new-onset angina diagnosed within the 3 months prior to screening. * History of myocardial infarction within 3 months prior to screening, as determined by medical history / Baseline ECG. * Uncontrolled cardiac arrhythmias (≥Grade 3 CTCAE version 5.0) or any history of ≥Grade 3 arrhythmia. * Congestive heart failure ≥New York Heart Association Class 2. * Clinically significant abnormalities on ECG at screening including corrected QT interval (Fridericia's formula) \>450 msec for males or 470 msec for females at screening. * Inability to complete the needed investigational and standard imaging examinations due to any reason (eg, severe claustrophobia, inability to lie still for the entire imaging time). * Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study Investigator, would make the participant inappropriate for entry into the study. * Participants with active infections (human immunodeficiency virus, human papillomavirus. Hepatitis A, Hepatitis B, and Hepatitis C).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Biogenix Molecular, LLC, CIRA Health
RECRUITINGMiami, Florida, 33165, United States
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Excel Diagnostics and Nuclear Oncology Center
RECRUITINGHouston, Texas, 77042, United States
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Houston Metro Urology
RECRUITINGHouston, Texas, 77027, United States
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NovaCure
RECRUITINGMiami, Florida, 33176, United States
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Oncology Consultants
RECRUITINGHouston, Texas, 77030, United States
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University of Texas Medical Branch at Galveston (UTMB)
RECRUITINGHouston, Texas, 77555, United States
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