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89Zr-DFOsq-olaratumab

Phase 1

Soft Tissue Sarcoma | Monoclonal antibody | Oncology |Telix Pharmaceuticals Limited|Trials Updated: Aug 14, 2026

89Zr-DFOsq-olaratumab target and mechanism

Molecular targetPDGFRα
Target class-Mab (Antibody)
ModalityMonoclonal antibody

Also known as 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

89Zr-DFOsq-olaratumab clinical trials

89Zr-DFOsq-olaratumab · 1 trial · 2 indications

Phase 1 1
NCT0653759689Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue SarcomaSoft Tissue Sarcoma
RECRUITING50 Analytics
PHASE1RECRUITING
89Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma
Soft Tissue SarcomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx
30 days

Number of Adverse events (AEs)

Biodistribution of 89Zr-TLX300-CDx
6 days

Measurement of absorbed radiation doses to organs.

Radiation dosimetry of 89Zr-TLX300-CDx
6 days

Measurement of absorbed radiation doses to tumour(s) and whole body.

Pharmacokinetics (PK)
6 days

Measure the antibody concentration at each timepoint to determine a PK curve.

Secondary Endpoints

Determine a suitable antibody mass for administration
6 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Part AEXPERIMENTALOne Injection of 89Zr-TLX300-CDx
Part BEXPERIMENTALOne Injection of 89Zr-TLX300-CDx
Part CEXPERIMENTALOne Injection of 89Zr-TLX300-CDx

Interventions

NameTypeDescription
89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)DRUGSingle administration of 89Zr-TLX300-CDx
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

INCLUSION CRITERIA: 1. ≥18 years of age at the time of signing the informed consent. 2. 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...

Countries:Australia
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Recent Changes (Last 90 Days)

MEDIUMAug 14, 2026NCT06537596primaryCompletionDate: changed
MEDIUMAug 14, 2026NCT06537596primaryCompletionDate: changed

Frequently asked questions about 89Zr-DFOsq-olaratumab

What is 89Zr-DFOsq-olaratumab?

89Zr-DFOsq-olaratumab is an investigational monoclonal antibody imaging agent being developed by Telix Pharmaceuticals Limited for soft tissue sarcoma. It combines the antibody olaratumab with the radioisotope zirconium-89 to visualize PDGFR alpha positive tumors. It is currently in Phase 1 clinical development and is not approved for commercial use.

What is 89Zr-DFOsq-olaratumab used for in soft tissue sarcoma?

89Zr-DFOsq-olaratumab is being studied for use in soft tissue sarcoma and other PDGFR alpha positive solid tumors. It is designed as a diagnostic imaging agent to help identify and characterize tumors that express PDGFR alpha. The research is in Phase 1 and the drug has not been approved for any indication.

What does 89Zr-DFOsq-olaratumab target?

89Zr-DFOsq-olaratumab targets PDGFR alpha, a receptor tyrosine kinase found on certain tumor cells. The antibody component olaratumab binds to PDGFR alpha, and the attached zirconium-89 radioisotope allows positron emission tomography imaging of PDGFR alpha expression in tumors. This targeting mechanism is under investigation in a Phase 1 trial.

Who is developing 89Zr-DFOsq-olaratumab?

89Zr-DFOsq-olaratumab is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. Telix is an Australian radiopharmaceutical company focused on diagnostic and therapeutic products. The company is sponsoring the Phase 1 clinical trial of this imaging agent.

What phase is 89Zr-DFOsq-olaratumab in?

89Zr-DFOsq-olaratumab is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA or any regulatory agency. The Phase 1 trial is currently recruiting participants and is designed to evaluate dosimetry in patients with PDGFR alpha positive solid tumors and soft tissue sarcoma.

What clinical trials is 89Zr-DFOsq-olaratumab in?

89Zr-DFOsq-olaratumab is being studied in one clinical trial, NCT06537596, titled '89Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma.' This Phase 1 trial is recruiting up to 50 participants in Australia and is currently active.

Is 89Zr-DFOsq-olaratumab the same as 89Zr-TLX300-CDx?

Yes, 89Zr-DFOsq-olaratumab is also known as 89Zr-TLX300-CDx. Both names refer to the same investigational imaging agent developed by Telix Pharmaceuticals. The 'CDx' suffix indicates its intended use as a companion diagnostic, while 'DFOsq' refers to the linker chemistry used to attach zirconium-89 to the antibody.