89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
- Registration Number
- NCT06537596
- Lead Sponsor
- Telix Pharmaceuticals (Innovations) Pty Ltd
- Brief 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part C 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) One Injection of 89Zr-TLX300-CDx Part A 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) One Injection of 89Zr-TLX300-CDx Part B 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) One Injection of 89Zr-TLX300-CDx
- Primary Outcome Measures
Name Time Method Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx 30 days Number of Adverse events (AEs)
Biodistribution of 89Zr-TLX300-CDx 6 days Measurement of absorbed radiation doses to organs.
Radiation dosimetry of 89Zr-TLX300-CDx 6 days Measurement of absorbed radiation doses to tumour(s) and whole body.
Pharmacokinetics (PK) 6 days Measure the antibody concentration at each timepoint to determine a PK curve.
- Secondary Outcome Measures
Name Time Method Determine a suitable antibody mass for administration 6 days SUV values of tumour lesions and tumour to background organ (e.g. blood/liver/muscle) ratios.
Trial Locations
- Locations (1)
Precision Molecular Imaging & Theranostics Pty Ltd
🇦🇺Melbourne, Victoria, Australia