Bone PainPhase 1SOLACENCT07197645
Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage Bone Pain
A Phase 1 study testing 153Sm-DOTMP in people with Bone Pain and Metastatic Bone Tumor, run by Telix Pharmaceuticals (Innovations) Pty Limited at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Pain, Metastatic Bone Tumor, Bone Metastases in Subjects With Advanced Cancer
- What is being tested?
- 153Sm-DOTMP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Oct 2025to 5 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sapna Shah, MD contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Houston Metro Urology
Houston, Texas, 77027
Lena Ellis, lena.ellis@hmutx.com
Than John Van
- Recruiting
Oncology Consultants
Houston, Texas, 77030
Laura Guerra, lguerra@oncologyconsultants.com
Julio Peguero
- Recruiting
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042
Britney Stewart, bstewart@exceldiagnostics.com
Ebrahim Delpassand
- Recruiting
University of Texas Medical Branch at Galveston (UTMB)
Houston, Texas, 77555
Jessica Robertson, CCRP, 409-772-1983, jearober@utmb.edu
David R. Cardoza-Ochoa, MD
- Recruiting
Biogenix Molecular, LLC, CIRA Health
Miami, Florida, 33165
Jerry Joseph, FMD, Site Administrator, 7867911799, jjoseph@cira-health.com
Julio Cordero, MD
- Recruiting
NovaCure
Miami, Florida, 33176
Anibal Serguei, Site Director, 7864850770, amunguia@novacurehealth.com
Serguei R. Castaneda, MD
About this study
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
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.
- Being tested
- 153Sm-DOTMP
- Keywords
- samarium, radioligand, radioisotope, metastatic bone pain palliation, Samarium-153, DOTMP, bone-seeking radiopharmaceutical
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
153Sm-DOTMPDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Cohort 1 | Experimental | Dose Escalation Receives: Drug: 153Sm-DOTMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs) [Safety and Tolerability]
Incidence and severity of hematologic and non-hematologic toxicities, graded per CTCAE v5.0, assessed through 6 weeks post-dose.
Measured: Up to 6 weeks post-dose
Secondary outcomes (1)
Change from baseline in patient-reported bone pain severity using the NRS-11 scale on the form
Change in pain score using NRS-11, assessed up to 16 weeks post-dose.
Measured: Baseline to 16 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start21 Oct 2025
- Primary completion26 Apr 2027 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197645
- Sponsor's protocol ID
- 153Sm-TLX090-101
- Acronym
- SOLACE
- Status last verified
- May 2026
- First submitted
- 30 Jul 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07197645
- Acronym / sponsor ID
- SOLACE / 153Sm-TLX090-101
- Keywords
- samarium, radioligand, radioisotope, metastatic bone pain palliation, Samarium-153, DOTMP, bone-seeking radiopharmaceutical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 26 Apr 2027 (estimated)
- Study completion
- 5 Jul 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part A - Cohort 1 | Experimental | Drug: 153Sm-DOTMPDose Escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 153Sm-DOTMPTLX090-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. | Drug | Part A - Cohort 1 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs) [Safety and Tolerability]
Time frame: Up to 6 weeks post-dose
Incidence and severity of hematologic and non-hematologic toxicities, graded per CTCAE v5.0, assessed through 6 weeks post-dose.
1 secondary outcome
Change from baseline in patient-reported bone pain severity using the NRS-11 scale on the form
Time frame: Baseline to 16 weeks post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
Related trials for Bone Pain
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
RecruitingObservational study
Fibrous Dysplasia: An Epidemiological and Correlational Evaluation of Multimodal Data
Fibrous Dysplasia, Fibrous Dysplasia of Bone
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sapna Shah, MD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 153Sm-DOTMP in people with Bone Pain and Metastatic Bone Tumor, run by Telix Pharmaceuticals (Innovations) Pty Limited at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sahar Khan (248-469-2985 ext. +1, sahar.khan@telixpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) [Safety and Tolerability] (time frame: Up to 6 weeks post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.