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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Telix Pharmaceuticals (Innovations) Pty Limited

Investigators

  • 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)

October 21, 2025

Primary Completion (Estimated)

April 26, 2027

Study Completion (Estimated)

July 5, 2027

Study Registration Dates

First Submitted

July 30, 2025

First Submitted That Met QC Criteria

September 22, 2025

First Posted (Actual)

September 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Metastatic Bone Tumor

Clinical Trials on 153Sm-DOTMP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe