RecruitingPhase 1NCT06537596

89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma

An Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab (89Zr-TLX300-CDx) in Participants With Soft Tissue Sarcoma.

Sponsor

Telix Pharmaceuticals (Innovations) Pty Ltd

Enrollment

50 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma

Summary

Soft Tissue Sarcoma (STS) is a type of cancer that develops in soft tissues such as muscles, tendons, fat, blood vessels, and nerves. STSs generally express a protein called Platelet-Derived Growth Factor Receptor (PDGFR)α, which makes them a target for the development of STS therapies, such as olaratumab. Olaratumab has been identified as a promising candidate to which radioactive substances can be attached for imaging or therapeutic purposes. Thus, this first in human imaging trial aims to study olaratumab combined with a radioactive metal called zirconium-89 (89Zr-TLX300-CDx) as a potential new product that may be used for STS imaging and identification of patients that may benefit from future treatments targeting PDGFRα.

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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