89Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTelix Pharmaceuticals (Innovations) Pty Ltd
About this trial
Soft Tissue Sarcoma (STS) is a cancer of soft tissues that often expresses Platelet-Derived Growth Factor Receptor (PDGFR)α, a potential therapeutic target. PDGFRα is also found in other advanced solid tumours.
Olaratumab, a PDGFRα-targeted antibody, may be used to deliver radioactive isotopes for imaging or therapy. This first-in-human study will evaluate zirconium-89-labelled olaratumab (⁸⁹Zr-TLX300-CDx) for imaging in patients with STS, selected PDGFRα-positive solid tumours and identification of patients that may benefit from future treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age at the time of signing the informed consent.
Histologically confirmed diagnosis of soft tissue sarcoma (STS). Patients with indications other than STS, that could be PDGFRα positive, will also be considered This would be subject to case-by-case approval by the Sponsor.
At least one mass of > 2cm in largest diameter seen on standard care imaging (CT or MRI) or at least one lesion detected positive via FDG-PET.
Participants must have consented to provide prior/archival FFPE tumour tissue or biopsy/resected tissues collected up to 30 days after visit 2 (89Zr-TLX300-CDx administration) - please refer to the Laboratory manual for description of tissue requirements.
Disqualifiers
Known or suspected hypersensitivity to olaratumab, DFOsq, 89Zr or any of the excipients.
IgE antibodies against galactose-α-1,3-galactose (α-Gal) above the ULN, >0.7 kU/L.
Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX300-CDx.
Surgery ≤ 2 weeks prior to the administration of 89Zr-TLX300-CDx or significant ongoing complications of surgery. Biopsy ≤ 2 weeks prior to the administration of 89Zr-TLX300-CDx is allowed.
Trial design
Design model
Parallel
Treatments tested in this trial
89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
DrugSingle administration of 89Zr-TLX300-CDx
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Part AExperimental treatment 1 intervention
Group B: Part BExperimental treatment 1 intervention
Group C: Part CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx
Number of Adverse events (AEs)
Time frame
30 days2
Biodistribution of 89Zr-TLX300-CDx
Measurement of absorbed radiation doses to organs.
Time frame
6 days3
Radiation dosimetry of 89Zr-TLX300-CDx
Measurement of absorbed radiation doses to tumour(s) and whole body.
Time frame
6 days4
Pharmacokinetics (PK)
Measure the antibody concentration at each timepoint to determine a PK curve.
Time frame
6 daysSecondary outcomes
1
Determine a suitable antibody mass for administration
SUV values of tumour lesions and tumour to background organ (e.g. blood/liver/muscle) ratios.
Time frame
6 daysOther outcomes
1
Evaluate the correlation between tumour uptake of 89Zr-TLX300-CDx and PDGFRα expression
Immunohistochemistry expression of PDGFRα in tumour tissue AND SUV tumour values and tumour to background ratios.
Time frame
30 days2
Compare the tumour uptake and detection of lesions between 89Zr-TLX300-CDx and standard of care imaging
89Zr-TLX300-CDx uptake within tumours and organs and Localisation of tumour deposits on conventional imaging (CT, MRI and/or FDGPET)
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov