RecruitingPhase 1NCT06537596

89Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma

An Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab (89ZrTLX300-CDx) in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma


Sponsor

Telix Pharmaceuticals (Innovations) Pty Ltd

Enrollment

50 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Soft Tissue Sarcoma (STS) is a cancer of soft tissues that often expresses Platelet-Derived Growth Factor Receptor (PDGFR)α, a potential therapeutic target. PDGFRα is also found in other advanced solid tumours. Olaratumab, a PDGFRα-targeted antibody, may be used to deliver radioactive isotopes for imaging or therapy. This first-in-human study will evaluate zirconium-89-labelled olaratumab (⁸⁹Zr-TLX300-CDx) for imaging in patients with STS, selected PDGFRα-positive solid tumours and identification of patients that may benefit from future treatments.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special radioactive imaging agent called 89Zr-olaratumab to scan soft tissue sarcomas (rare cancers of muscle, fat, or connective tissue). The goal is to understand how much of the drug reaches the tumor and how it behaves in the body, which is important for developing it as a future targeted treatment. **You may be eligible if...** - You are 18 or older with a confirmed soft tissue sarcoma - You have at least one tumor larger than 2 cm visible on standard imaging - Your blood counts and organ function meet minimum safety thresholds - You are willing to provide a tumor tissue sample (or have one archived) **You may NOT be eligible if...** - Your tumor cannot be biopsied or imaged adequately - Your organ function is too poor to safely receive the imaging agent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)

Single administration of 89Zr-TLX300-CDx


Locations(3)

Princess Alexandra Hospital 199 Ipswich Road, Woolloongabba

Brisbane, Queensland, Australia

Precision Molecular Imaging & Theranostics Pty Ltd

Melbourne, Victoria, Australia

GenesisCare Murdoch 100 Murdoch Drive, Murdoch WA

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT06537596


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