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

Part of paid clinical trials in Miami, Florida.

Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited
Study ID
NCT07197645
Phase
PHASE1
Status
Recruiting
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Conditions

  • Bone Metastases in Subjects With Advanced Cancer
  • Bone Pain
  • Metastatic Bone Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 153Sm-DOTMP — DRUG
    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 Details

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.

Key Dates

Start date
Oct 21, 2025
Status verified
May 2026
Primary completion
Apr 26, 2027
Completion
Jul 5, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Part A - Cohort 1
    Dose Escalation

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

Locations (6)

FacilityCityStateZIPSite coordinators
Biogenix Molecular, LLC, CIRA HealthMiamiFlorida33165
Jerry Joseph, FMD, Site Administrator
[email protected]
7867911799
Julio Cordero, MD (PRINCIPAL_INVESTIGATOR)
NovaCureMiamiFlorida33176
Anibal Serguei, Site Director
[email protected]
7864850770
Serguei R. Castaneda, MD (PRINCIPAL_INVESTIGATOR)
Excel Diagnostics and Nuclear Oncology CenterHoustonTexas77042
Britney Stewart
[email protected]
Ebrahim Delpassand (PRINCIPAL_INVESTIGATOR)
Houston Metro UrologyHoustonTexas77027
Than John Van (PRINCIPAL_INVESTIGATOR)
Oncology ConsultantsHoustonTexas77030
Laura Guerra
[email protected]
Julio Peguero (PRINCIPAL_INVESTIGATOR)
University of Texas Medical Branch at Galveston (UTMB)HoustonTexas77555
Jessica Robertson, CCRP
[email protected]
409-772-1983
David R. Cardoza-Ochoa, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Biogenix Molecular, LLC, CIRA Health· Miami, FLNovaCure· Miami, FLExcel Diagnostics and Nuclear Oncology Center· Houston, TXHouston Metro Urology· Houston, TXOncology Consultants· Houston, TXUniversity of Texas Medical Branch at Galveston (UTMB)· Houston, TX

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