Actively Recruiting
An Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab in Participants With Soft Tissue Sarcoma
Led by Telix Pharmaceuticals (Innovations) Pty Ltd · Updated on 2024-12-19
50
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Soft Tissue Sarcoma (STS) is a cancer that forms in soft tissues like muscles, tendons, fat, blood vessels, and nerves. These tumors often have a protein called PDGFRb1, which is targeted by treatments such as olaratumab. This trial is evaluating a new imaging agent, 89Zr-TLX300-CDx, which combines olaratumab with a radioactive metal, zirconium-89, to help detect STS and identify patients who might benefit from future PDGFRb1-targeted therapies. Participants will receive a single injection of 89Zr-TLX300-CDx and undergo whole-body imaging at various times depending on the study part. Part A and B include imaging at about 6 days after injection, with optional imaging at 4 hours. Part C involves imaging at 24 hours, 4 days, and 7 days post-injection, plus optional early dynamic imaging. Blood samples will be taken before injection and at multiple time points afterwards to study how the drug moves through the body. During the study, participants will have imaging scans and blood collections to assess safety, how the drug spreads and is processed, radiation exposure, and tumor targeting. The primary outcomes include safety and tolerability over 30 days, biodistribution and radiation dosimetry at 6 days, and pharmacokinetics. The study will help guide the future use of olaratumab as a radiopharmaceutical for STS. Participation involves visits for injections, imaging, and blood tests, with monitoring continuing for up to 30 days.
CONDITIONS
Brief 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
- For Part A: tumor PDGFRb1 expression confirmed by immunohistochemistry
- For Parts B and C: consent to provide archived tumor tissue
- Adequate blood counts: ANC 200/ bcL, hemoglobin 9.0 g/dL, platelets 10,000/bcL
- Adequate liver function: total bilirubin 1.5 mg/dL, AST and ALT 3 times upper limit of normal
- Adequate kidney function: serum creatinine 1.5 times upper limit of normal or creatinine clearance 45 mL/min
- ECOG performance status 0 to 2
- Life expectancy of at least 6 months
- Female participants of childbearing potential must have negative pregnancy tests and use effective contraception
- Able to give informed consent and comply with study requirements
You will not qualify if you...
- Known or suspected allergy to olaratumab, DFOsq, zirconium-89, or any study components
- Elevated IgE antibodies to galactose-b1-1,3-galactose above normal
- Use of experimental drugs within 30 days before study drug administration
- Surgery within 2 weeks before study drug administration or ongoing surgical complications
- Use of radiopharmaceuticals within 10 half-lives before study drug administration
- Ongoing moderate or worse toxicity from previous therapies
- Planned cancer treatments during the study period
- Serious diseases that may interfere with study objectives or safety
- Pregnant or breastfeeding women
- Unable to give informed consent or tolerate study procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments
Duration - Up to 7 days post-injection
Participants receive a single injection of 89Zr-TLX300-CDx followed by multiple imaging and blood collection visits to evaluate safety, pharmacokinetics, and radiation dosimetry.
1 injection visit and 2 to 4 imaging visits plus 3 to 5 blood collection visits depending on study part
Duration - Up to 30 days
Participants are monitored for safety and tolerability for up to 30 days after the injection.
Follow-up visits as needed for safety assessments
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
V
Vanessa Penna, Ph.D
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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