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

May 12, 2026 updated by: Telix Pharmaceuticals (Innovations) Pty Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33165
        • Recruiting
        • Biogenix Molecular, LLC, CIRA Health
        • Contact:
        • Principal Investigator:
          • Julio Cordero, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • NovaCure
        • Contact:
        • Principal Investigator:
          • Serguei R. Castaneda, MD
    • Texas
      • Houston, Texas, United States, 77027
        • Recruiting
        • Houston Metro Urology
        • Contact:
        • Principal Investigator:
          • Than John Van
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77042
        • Recruiting
        • Excel Diagnostics and Nuclear Oncology Center
        • Contact:
        • Principal Investigator:
          • Ebrahim Delpassand
      • Houston, Texas, United States, 77555
        • Recruiting
        • University of Texas Medical Branch at Galveston (UTMB)
        • Contact:
        • Principal Investigator:
          • David R. Cardoza-Ochoa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A - Cohort 1
Dose Escalation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 6 weeks post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change in pain score using NRS-11, assessed up to 16 weeks post-dose.
Baseline to 16 weeks post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Telix Pharmaceuticals (Innovations) Pty Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Namrata Chand, Telix Pharmaceuticals (Innovations) Pty Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 153Sm-TLX090-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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