89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma

Sponsor
Telix Pharmaceuticals (Innovations) Pty Ltd
Study ID
NCT06537596
Phase
PHASE1
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

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

Interventions

  • 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) — DRUG
    Single administration of 89Zr-TLX300-CDx

Study Details

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.

Key Dates

First listed
Aug 5, 2024
Start date
Oct 31, 2024
Status verified
Dec 2024
Primary completion
Mar 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Part A
    One Injection of 89Zr-TLX300-CDx
  • Experimental: Part B
    One Injection of 89Zr-TLX300-CDx
  • Experimental: Part C
    One Injection of 89Zr-TLX300-CDx

Primary Outcome Measure

Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx [ Time Frame: 30 days ]

Central Contacts

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