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
Qualifiers
≥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
Treatments tested in this trial
- 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov