TheranosticTrials.org
Telix Pharmaceuticals

Clinical Trial · NCT06537596

89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma (ZOLAR)

Overview

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.

Sponsor

Telix Pharmaceuticals

Phase

Phase 1

Contacts

Vanessa Penna (Clinical Project Manager)

vanessa.penna@telix.pharma.com

+61 9093 3880

Brenda Cerqueira (Senior Director, Clinical Operations)

brenda.cerqueria@telixpharma.com

+61 83180090

ClinicalTrials.gov

NCT06537596

Eligibility

Inclusion

  • Part A: Tumor PDGFRα expression confirmed by IHC; Part B and C: All patients regardless of PDGFRα status
  • >= 18 years of age
  • At least one mass >2 cm seen on CT, MRI and/or FDG-PET
  • Histologically confirmed diagnosis of soft tissue sarcoma (STS)

Exclusion

  • IgE antibodies against galactose-α-1,3-galactose (α-Gal) above the upper limit of normal, >0.7 kU/L
  • Surgery <=2 weeks priorto administration or significant ongoing complications of surgery; biopsy <=2 weeks prior allowed
  • Planned to commence systemic antineoplastic-, immuno-, targeted-, radiotherapies &/or surgery between admin and imaging
  • Exposure to any radiopharmaceutical within 10 half-lives prior to administration

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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