Actively Recruiting
89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
Led by Telix Pharmaceuticals (Innovations) Pty Ltd · Updated on 2024-12-19
50
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Histologically confirmed diagnosis of soft tissue sarcoma
- At least one tumor mass larger than 2 cm on standard imaging (CT, MRI, or FDG-PET)
- For Part A: tumor PDGFRb1 expression confirmed by immunohistochemistry (IHC) with consent to provide archived or new biopsy tissue
- For Parts B and C: consent to provide available archived tumor tissue regardless of PDGFRb1 status
- Adequate blood cell counts: neutrophils 4 1500/bcL, hemoglobin 4 9.0 g/dL, platelets 4 100,000/bcL
- Adequate liver function: total bilirubin 3 1.5 mg/dL, AST and ALT 3 times upper limit of normal
- Adequate kidney function: serum creatinine 4 1.5 times institutional upper limit or creatinine clearance 4 45 mL/min if elevated
- ECOG performance status between 0 and 2
- Life expectancy of at least 6 months
- Female participants of childbearing potential must have negative pregnancy tests and agree to effective contraception or abstinence; males with partners of childbearing potential must agree to contraception
- Ability to give informed consent and comply with study requirements
You will not qualify if you...
- Known or suspected allergy to olaratumab, DFOsq, 89Zr, or any study excipients
- IgE antibodies against galactose-1-1,3-galactose above 0.7 kU/L
- Use of experimental diagnostic or therapeutic drugs within 30 days before study drug administration
- Surgery within 2 weeks before study drug administration or unresolved surgical complications (biopsy within 2 weeks allowed)
- Exposure to radiopharmaceuticals within 10 half-lives before study drug administration
- Ongoing moderate or higher toxicity (Grade 2 or above) from prior therapies
- Planned systemic cancer treatments or surgery during the study imaging period
- Serious non-cancer diseases that could affect study participation or safety
- Pregnant or breastfeeding women
- Unable to provide informed consent or tolerate study procedures due to mental or legal reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Precision Molecular Imaging & Theranostics Pty Ltd
Melbourne, Victoria, Australia, 3051
Actively Recruiting
Research Team
B
Brenda Cerqueira, M.Sc
CONTACT
V
Vanessa Penna, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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