OncoMatch/Clinical Trials/NCT06537596
89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
Is NCT06537596 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) for soft tissue sarcoma.
Treatment: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Required: PDGFRA overexpression (confirmed by IHC)
For Part A: Participants must have tumour PDGFRα expression confirmed by IHC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: experimental diagnostic or therapeutic drug
Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX300-CDx
Cannot have received: radiopharmaceutical
Exposure to any radiopharmaceutical within 10 half-lives prior to the administration of 89Zr-TLX300-CDx
Lab requirements
Blood counts
ANC ≥ 1500/μL, haemoglobin ≥ 9.0 g/dL, and platelet count of 100,000/μL
Kidney function
serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, creatinine clearance ≥ 45 mL/min
Liver function
total bilirubin ≤ 1.5 mg/dL, and AST and ALT ≤ 3.0 times the upper limit of normal (ULN)
Adequate haematologic function as defined by an absolute neutrophil count (ANC) ≥ 1500/ μL, haemoglobin ≥ 9.0 g/dL, and a platelet count of 100,000/μL obtained. Adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper limit of normal (ULN). Adequate renal function as defined by serum creatinine ≤ 1.5 × the institutional ULN. If creatinine is above the ULN, the participant's creatinine clearance is ≥ 45 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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