OncoMatch/Clinical Trials/NCT06537596
89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
Is NCT06537596 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06537596 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior experimental diagnostic or therapeutic drug, radiopharmaceutical disqualifies patients from enrollment.
Does this trial require PDGFRA?
Yes, PDGFRA overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages