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89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
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.
Study details:
Platelet-derived growth factor receptor α (PDGFRα) is expressed on soft tissue sarcoma (STS) where it could act as a potential therapeutic target. Olaratumab is a PDGFRα-targeted antibody that has the potential to act as the targeting moiety for both imaging and therapeutic radioisotopes. Olaratumab's demonstrated safety profile and its ability to target PDGFRα on STS cell surfaces and be rapidly internalised, make it a promising candidate for use as a radionuclide targeting agent in STS.
89Zr-TLX300-CDx is being developed for PDGFRα molecular imaging with positron emission tomography (PET) in STS. The aim of this study is to provide proof-of-concept tumour targeting of 89Zr-TLX300-CDx and assess the safety and radiation dosimetry of radiolabelled olaratumab. This study will inform future development of olaratumab as a therapeutic radiopharmaceutical agent in STS.
SCHEDULE OF ASSESSMENTS. Part A and B:. IMAGING:.
1 single injection of 89Zr-TLX300-CDx on Day 1 and whole-body imaging at 6 days ± 1 day post-injection. Blood Collection for PHARMACOKINETICS:. Pre-injection, 4h ± 0.
5h and 6 days ± 1 day post-injection. OPTIONAL:. Imaging at 4h ± 0.
5h post-injection. Part C:. IMAGING:.
1 single injection of 89Zr-TLX300-CDx on Day 1, whole-body imaging at 24h ± 4h post-injection, whole-body imaging at 4 days ± 1 post-injection and whole-body imaging at 7 days ± 1 day post-injection. Blood collection for PHARMACOKINECTCS:. Pre-injection, 4h ± 0.
5h, 24h ± 4h, 4 days ± 1 day and 7 days ± 1 day post-injection. OPTIONAL:. Dynamic imaging 15 min ± 2 min post-injection at selected sites (extended field-of-view scanner is available), imaging at 4h ± 0.
5h post-injection and imaging at 7h ± 1hpost-injection.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-01
Primary completion: 2025-12-01
Study completion finish: 2026-06-01
Study type
DIAGNOSTIC
Phase
PHASE1
Trial ID
NCT06537596
Intervention or treatment
DRUG: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Conditions
- • Soft Tissue Sarcoma
Find a site
Closest Location:
Melbourne Theranostic Innovation Centre
Research sites nearby
Select from list below to view details:
Melbourne Theranostic Innovation Centre
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part A
| DRUG: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
|
EXPERIMENTAL: Part B
| DRUG: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
|
EXPERIMENTAL: Part C
| DRUG: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx | Number of Adverse events (AEs) | 30 days |
Biodistribution and radiation dosimetry of 89Zr-TLX300-CDx | Measurement of absorbed radiation doses to organs (Gy/MBq), tumour(s) and whole body (Sv/MBq). | 6 days |
Pharmacokinetics (PK) | Measure the antibody concentration at each timepoint to determine a PK curve. | 6 days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Determine a suitable antibody mass for administration | SUV (max, mean) values of tumour lesions and tumour to background organ (e.g. blood/liver/muscle) ratios. | 6 days |
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