Can a radioactive antibody light up hidden tumors?
NCT ID NCT06537596
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial is testing an experimental imaging agent called 89Zr-olaratumab in people with soft tissue sarcoma or other solid tumors that express a protein called PDGFRα. The agent is a radioactive-labeled antibody designed to bind to PDGFRα and show up on PET scans, potentially revealing tumors and helping doctors see who might benefit from future targeted therapies. The study will assess the safety, tolerability, and imaging properties of this agent in about 50 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A radioactive imaging agent called 89Zr-olaratumab (89Zr-TLX300-CDx), which is an antibody that targets PDGFRα and carries a radioactive label for PET imaging.
- What this could lead to
- If successful, this could lead to a new imaging method to identify patients with PDGFRα-positive tumors who might benefit from targeted treatments.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the imaging agent may not work as hoped or may cause unexpected side effects. Results are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 the Sponsor. 3. At least one mass of \> 2cm in largest diameter seen on standard care imaging (CT or MRI) or at least one lesion detected positive via FDG-PET. 4. Participants must have consented to provide prior/archival FFPE tumour tissue or biopsy/resected tissues collected up to 30 days after visit 2 (89Zr-TLX300-CDx administration) - please refer to the Laboratory manual for description of tissue requirements. It is preference that biopsies have been collected within 3 months of trial participation (but not mandatory). 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. 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 CRITERIA: 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 ULN, \>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. 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, i.e., (Visit 4 for Parts A and B; Visit 5 for Part C). Existing or ongoing therapies may be continued during the imaging window, without washout period. 7. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic), unresolved serious symptoms from previous therapies, 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. 8. Pregnant or lactating person. 9. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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GenesisCare Murdoch 100 Murdoch Drive, Murdoch WA
NOT_YET_RECRUITINGPerth, Western Australia, 6150, Australia
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Precision Molecular Imaging & Theranostics Pty Ltd
RECRUITINGMelbourne, Victoria, 3051, Australia
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Princess Alexandra Hospital 199 Ipswich Road, Woolloongabba
RECRUITINGBrisbane, Queensland, 4102, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a One-Two punch of immunotherapy and radiation tame sarcoma before surgery?
- A simple blood test may reveal hidden infertility risk in young cancer survivors
- Could a massive tissue bank unlock sarcoma's secrets?
- Can a targeted pill stall advanced sarcomas?