Recruiting
Phase 1

TLX090-Tx

Sponsor:

Telix Pharmaceuticals (Innovations) Pty Limited

Code:

NCT07197645

Conditions

Bone Pain

Metastatic Bone Tumor

Bone Metastases in Subjects With Advanced Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

153Sm-DOTMP

Study Details

Brief 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.

Conditions

Bone Pain

Metastatic Bone Tumor

Bone Metastases in Subjects With Advanced Cancer

Study ID

NCT07197645

Start date

Oct 21, 2025

Status verified date

May, 2026

Completion date

Jul 5, 2027

Anticipated

Primary completion date

Apr 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

33 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Part A - Cohort 1

Dose Escalation

Interventions

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.

Primary outcome measure

  • Incidence and severity of treatment-emergent adverse events (TEAEs) [Safety and Tolerability] [ Time Frame: Up to 6 weeks post-dose ]

Central Contacts and Locations

Central contacts

Sahar Khan

248-469-2985sahar.khan@telixpharma.com

Sapna Shah, MD

sapna.shah@telixpharma.com

Locations

Biogenix Molecular, LLC, CIRA Health

Recruiting

Miami, Florida, United States, 33165

Contacts

Jerry Joseph, FMD, Site Administrator

7867911799jjoseph@cira-health.com

Principal Investigator:

Julio Cordero, MD

NovaCure

Recruiting

Miami, Florida, United States, 33176

Contacts

Anibal Serguei, Site Director

7864850770amunguia@novacurehealth.com

Principal Investigator:

Serguei R. Castaneda, MD

Houston Metro Urology

Recruiting

Houston, Texas, United States, 77027

Contacts

Lena Ellis

lena.ellis@hmutx.com

Principal Investigator:

Than John Van

Oncology Consultants

Recruiting

Houston, Texas, United States, 77030

Contacts

Laura Guerra

lguerra@oncologyconsultants.com

Principal Investigator:

Julio Peguero

Excel Diagnostics and Nuclear Oncology Center

Recruiting

Houston, Texas, United States, 77042

Contacts

Britney Stewart

bstewart@exceldiagnostics.com

Principal Investigator:

Ebrahim Delpassand

University of Texas Medical Branch at Galveston (UTMB)

Recruiting

Houston, Texas, United States, 77555

Contacts

Jessica Robertson, CCRP

409-772-1983jearober@utmb.edu

Principal Investigator:

David R. Cardoza-Ochoa, MD

More Information

Sponsor

Telix Pharmaceuticals (Innovations) Pty Limited

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • samarium
  • radioligand
  • radioisotope
  • metastatic bone pain palliation
  • Samarium-153
  • DOTMP
  • bone-seeking radiopharmaceutical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Telix Pharmaceuticals (Innovations) Pty Limited on 2026-05-14.