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RecruitingLast updated: 10 October 2025

ZOLAR: This study is recruiting people with soft tissue sarcoma to test a new targeted diagnostic method.An Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab (89Zr-TLX300-CDx) in Participants With Soft Tissue Sarcoma.

Trial purpose

Medical clipboardDiagnostic

Tumor type

Sarcoma Cancers Sarcoma

Age

People18+

Trial acronym

ZOLAR

Clinical summary

Summary

Researchers are studying a new way to detect and treat soft tissue sarcoma (STS). STS cells often have a protein called PDGFRα on their surface. A medicine called olaratumab can attach to this protein, which makes it useful for both finding and treating cancer.

In this study, researchers are testing a version of olaratumab that's combined with a small amount of radioactive material called zirconium-89. This may help doctors see the cancer better on scans, and may also help deliver radiation directly to the cancer cells in future treatments.

This study will check how well this new approach works in targeting tumours, and see how safe it is.

What's involved

The study has three parts. Part A will enrol people confirmed tumour PDGFRα expression, and Parts B and C will include all participants regardless of their PDGFRα expression status on archival tissue or biopsy.

In Parts A and B, participants will receive an injection of olaratumab combined with zirconium-89 (called 89Zr-TLX300-CDx) on Day 1 and receive whole-body imaging around 6 days later.

Blood tests will also be completed before the injection,around 4 hours after the injection, and again about 6 days later. There is also an optional scan that may be completed 4 hours after the injection.

In Part C, participants will receive an injection of 89Zr-TLX300-CDx on Day 1, receive whole-body imaging around 24 hours later, and again 4 days and 7 days after the injection.

Blood tests will be completed before the injection, and after the injection at timepoints of 4 hours, 24 hours, 4 days and 7 days. There are also optional dynamic imaging that may be completed 15 minutes after the injection, as well as after 4 hours and 7 hours.

Conditions

This trial is treating people with soft tissue sarcoma

Eligibility

Inclusion

  1. ≥18 years of age at the time of signing the informed consent.
  2. Histologically confirmed diagnosis of soft tissue sarcoma (STS)
  3. At least one mass of > 2 cm in largest diameter seen on standard of care imaging (CT, MRI and/or FDG-PET).

  4. For Part A: Participants must have tumour PDGFRα expression confirmed by IHC. Participants must have consented to provide archived FFPE tumour tissue or be subject to a biopsy of the target tumour (if archived tissue is unavailable).

    For Parts B and C: all participants will be included regardless of their PDGFRα expression status on archival tissue/biopsy (unless otherwise specified). Participants must have consented to provide available archived FFPE tumour tissue.

  5. 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.
  6. 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).
  7. 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.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  9. Life expectancy of at least 6 months.

  10. Female participants of childbearing potential must have negative pregnancy tests at screening, as well as confirmation of negative pregnancy test result within 24 hours prior to receiving 89Zr-TLX300-CDx. Female participants of childbearing potential or male participants with female partners of childbearing potential must:

    1. be willing to practice full and true sexual abstinence; or
    2. be surgically/permanently sterile or with a history of hysterectomy for women; or
    3. be willing to practice highly effective contraception by using: a non-oral, injected or implanted non-oestrogen progesterone based hormonal method, male condom, vaginal diaphragm, cervical cap, intrauterine device, for 3 months after the administration of 89Zr-TLX300-CDx.
  11. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion

  1. Known or suspected hypersensitivity to olaratumab, DFOsq, 89Zr or any of the excipients.
  2. IgE antibodies against galactose-α-1,3-galactose (α-Gal) above the upper limit of normal, > 0.7 kU/L.
  3. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX300-CDx.
  4. Surgery ≤ 2 weeks prior to the administration of 89Zr-TLX300-CDx or significant ongoing complications of surgery. Biopsy ≤ 2 weeks prior to the administration of 89Zr-TLX300-CDx is allowed.
  5. Exposure to any radiopharmaceutical within 10 half-lives prior to the administration of 89Zr-TLX300-CDx.
  6. Ongoing toxicity Grade 2 or higher from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events [CTCAE] version 5).
  7. Planned to commence systemic antineoplastic therapies, immunotherapy, targeted therapy, radiotherapy and/or surgery for the period between administration of 89Zr-TLX300-CDx and last imaging timepoint.
  8. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) or any disease that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.
  9. Pregnant or lactating women.
  10. Participants unable to declare meaningful informed consent on their own (e.g., with legal guardian for mental disorders) or unable to tolerate the study procedures.

Inclusion

  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Telix Pharmaceuticals (Innovations) Pty Ltd

Scientific Title

An Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab (89Zr-TLX300-CDx) in Participants With Soft Tissue Sarcoma.

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