Phase 1 Study of 89Zr-olaratumab Imaging to Assess Safety and Dosimetry in Adults With Soft Tissue Sarcoma

What this Trial Is About

Soft Tissue Sarcoma STS is a cancer that forms in soft tissues like muscles, tendons, fat, blood vessels, and nerves. These tumors often have a protein called PDGFRb1, which is targeted by treatments such as olaratumab. This trial is evaluating a new imaging agent, 89Zr-TLX300-CDx, which combines olaratumab with a radioactive metal, zirconium-89, to help detect STS and identify patients who might benefit from future PDGFRb1-targeted therapies. Participants will receive a single injection of 89Zr-TLX300-CDx and undergo whole-body imaging at various times depending on the study part. Part A and B include imaging at about 6 days after injection, with optional imaging at 4 hours. Part C involves imaging at 24 hours, 4 days, and 7 days post-injection, plus optional early dynamic imaging. Blood samples will be taken before injection and at multiple time points afterwards to study how the drug moves through the body. During the study, participants will have imaging scans and blood collections to assess safety, how the drug spreads and is processed, radiation exposure, and tumor targeting. The primary outcomes include safety and tolerability over 30 days, biodistribution and radiation dosimetry at 6 days, and pharmacokinetics. The study will help guide the future use of olaratumab as a radiopharmaceutical for STS. Participation involves visits for injections, imaging, and blood tests, with monitoring continuing for up to 30 days.

89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma