Soft Tissue SarcomaPhase 1ZOLARNCT06537596
89Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma
A Phase 1 study testing 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) in people with Soft Tissue Sarcoma and PDGFR Alpha Positive Solid Tumours, run by Telix Pharmaceuticals (Innovations) Pty Ltd at 3 sites in Australia.
Trial summary
Soft Tissue Sarcoma (STS) is a cancer of soft tissues that often expresses Platelet-Derived Growth Factor Receptor (PDGFR)α, a potential therapeutic target. PDGFRα is also found in other advanced solid tumours. Olaratumab, a PDGFRα-targeted antibody, may be used to deliver radioactive isotopes for imaging or therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, PDGFR Alpha Positive Solid Tumours
- What is being tested?
- 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesAustralia
- Study dates
- 31 Oct 2024to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at the time of signing the informed consent.
- 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.
- 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.
- 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).
- 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.
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- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 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:
- be willing to practice full and true sexual abstinence; or
- be surgically/permanently sterile or with a history of hysterectomy for women; or
- 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.
Who cannot join
- Known or suspected hypersensitivity to olaratumab, DFOsq, 89Zr or any of the excipients.
- IgE antibodies against galactose-α-1,3-galactose (α-Gal) above the ULN, >0.7 kU/L.
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX300-CDx.
- 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.
- Exposure to any radiopharmaceutical within 10 half-lives prior to the administration of 89Zr-TLX300-CDx.
- 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.
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- 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.
- Pregnant or lactating person.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Princess Alexandra Hospital 199 Ipswich Road, Woolloongabba
Brisbane, Queensland, 4102
Vladimir Andelkovic, +61731766577, vladimir.andelkovic@health.qld.gov.au
Loren Katchel, +617 3176 1810, Loren.Katchel@health.qld.gov.au
- Recruiting
Precision Molecular Imaging & Theranostics Pty Ltd
Melbourne, Victoria, 3051
Christopher Marinakis, MMedRad, BBSc, +61 3 94545804, cmarinakis@mtic.net.au
Jason Callahan, +61 3 94545804, jcallahan@mtic.net.au
- Not yet recruiting
GenesisCare Murdoch 100 Murdoch Drive, Murdoch WA
Perth, Western Australia, 6150
Aviral Singh, +61893661500, aviral.singh@genesiscare.com
Julie Rowe, 0498477691, julie.rowe@genesiscare.com
About this study
Official title: An Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab (89ZrTLX300-CDx) in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma
Soft Tissue Sarcoma (STS) is a cancer of soft tissues that often expresses Platelet-Derived Growth Factor Receptor (PDGFR)α, a potential therapeutic target. PDGFRα is also found in other advanced solid tumours.
Olaratumab, a PDGFRα-targeted antibody, may be used to deliver radioactive isotopes for imaging or therapy. This first-in-human study will evaluate zirconium-89-labelled olaratumab (⁸⁹Zr-TLX300-CDx) for imaging in patients with STS, selected PDGFRα-positive solid tumours and identification of patients that may benefit from future treatments.
Read the detailed description
Platelet-derived growth factor receptor α (PDGFRα) is expressed in soft tissue sarcoma (STS) and other solid tumours, where it may serve as a therapeutic target. Olaratumab is a PDGFRα-targeted antibody with potential to act as a targeting moiety for both imaging and therapeutic radioisotopes. Its favourable safety profile and ability to bind and be internalised by PDGFRα-expressing tumour cells make it a promising radionuclide targeting agent. ⁸⁹Zr-TLX300-CDx is being developed for PDGFRα PET imaging in STS and selected PDGFRα-positive solid tumours. The aim of this study is to demonstrate tumour targeting of ⁸⁹Zr-TLX300-CDx and assess its safety and radiation dosimetry, to support future development of olaratumab as a radiopharmaceutical.
SCHEDULE OF ASSESSMENTS
Part A
IMAGING:
1 single injection of 89Zr-TLX300-CDx on Day 1 followed by whole-body imaging at 4h ± 0.5h and Day 6 ± 1 post-injection.
OPTIONAL:
Imaging at Day 4 ± 1 post-injection.
Blood Collection for Pharmacokinectics:
Pre-injection, 4h ± 0.5h and 6 days ± 1 day post-injection.
OPTIONAL:
Blood collection at Day 4 ± 1 post-injection.
Part B
IMAGING:
1 single injection of 89Zr-TLX300-CDx on Day 1 followed by whole-body imaging at Day 6 ± 1 post-injection.
OPTIONAL:
Imaging at 4h ± 0.5h post-injection and at Day 4 ± 1 post-injection.
Blood Collection for Pharmacokinectics:
Pre-injection, 4h ± 0.5h and 6 days ± 1 day post-injection.
OPTIONAL:
Blood collection at Day 4 ± 1 post-injection.
Part C:
IMAGING:
1 single injection of 89Zr-TLX300-CDx on Day 1 followed by whole-body imaging at 24h ± 4h, 4 days ± 1 post-injection and 7 days ± 1 day post-injection.
OPTIONAL:
Dynamic imaging 15 min ± 2 min post-injection at selected sites (extended field-of-view scanner available) and static imaging at 4h ± 0.5h post-injection.
Blood Collection for Pharmacokinectics:
Pre-injection, 4h ± 0.5h, 24h ± 4h, 4 days ± 1 day and 7 days ± 1 day post-injection.
- Being tested
- 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
- Keywords
- Soft Tissue Sarcoma, Solid Tumours
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)Drug
Single administration of 89Zr-TLX300-CDx
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | One Injection of 89Zr-TLX300-CDx Receives: Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) |
| Part B | Experimental | One Injection of 89Zr-TLX300-CDx Receives: Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) |
| Part C | Experimental | One Injection of 89Zr-TLX300-CDx Receives: Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx
Number of Adverse events (AEs)
Measured: 30 days
Biodistribution of 89Zr-TLX300-CDx
Measurement of absorbed radiation doses to organs.
Measured: 6 days
Radiation dosimetry of 89Zr-TLX300-CDx
Measurement of absorbed radiation doses to tumour(s) and whole body.
Measured: 6 days
Pharmacokinetics (PK)
Measure the antibody concentration at each timepoint to determine a PK curve.
Measured: 6 days
Secondary outcomes (1)
Determine a suitable antibody mass for administration
SUV values of tumour lesions and tumour to background organ (e.g. blood/liver/muscle) ratios.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start31 Oct 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Proof-of-concept tumour targeting of 89Zr-TLX300-CDx (Part A), assessment of 89Zr-TLX300-CDx biodistribution and tumour uptake (Part B) and radiation dosimetry (Part C).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537596
- Sponsor's protocol ID
- 89Zr-TLX300-101
- Acronym
- ZOLAR
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Study to Assess Safety, Tolerability, Dosimetry, Pharmacokinetics and Imaging Properties of 89Zr-olaratumab (89ZrTLX300-CDx) in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT06537596
- Acronym / sponsor ID
- ZOLAR / 89Zr-TLX300-101
- Keywords
- Soft Tissue Sarcoma, Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Soft Tissue Sarcoma (STS) is a cancer of soft tissues that often expresses Platelet-Derived Growth Factor Receptor (PDGFR)α, a potential therapeutic target. PDGFRα is also found in other advanced solid tumours.
Olaratumab, a PDGFRα-targeted antibody, may be used to deliver radioactive isotopes for imaging or therapy. This first-in-human study will evaluate zirconium-89-labelled olaratumab (⁸⁹Zr-TLX300-CDx) for imaging in patients with STS, selected PDGFRα-positive solid tumours and identification of patients that may benefit from future treatments.
Detailed description
Platelet-derived growth factor receptor α (PDGFRα) is expressed in soft tissue sarcoma (STS) and other solid tumours, where it may serve as a therapeutic target. Olaratumab is a PDGFRα-targeted antibody with potential to act as a targeting moiety for both imaging and therapeutic radioisotopes. Its favourable safety profile and ability to bind and be internalised by PDGFRα-expressing tumour cells make it a promising radionuclide targeting agent. ⁸⁹Zr-TLX300-CDx is being developed for PDGFRα PET imaging in STS and selected PDGFRα-positive solid tumours. The aim of this study is to demonstrate tumour targeting of ⁸⁹Zr-TLX300-CDx and assess its safety and radiation dosimetry, to support future development of olaratumab as a radiopharmaceutical.
SCHEDULE OF ASSESSMENTS
Part A
IMAGING:
1 single injection of 89Zr-TLX300-CDx on Day 1 followed by whole-body imaging at 4h ± 0.5h and Day 6 ± 1 post-injection.
OPTIONAL:
Imaging at Day 4 ± 1 post-injection.
Blood Collection for Pharmacokinectics:
Pre-injection, 4h ± 0.5h and 6 days ± 1 day post-injection.
OPTIONAL:
Blood collection at Day 4 ± 1 post-injection.
Part B
IMAGING:
1 single injection of 89Zr-TLX300-CDx on Day 1 followed by whole-body imaging at Day 6 ± 1 post-injection.
OPTIONAL:
Imaging at 4h ± 0.5h post-injection and at Day 4 ± 1 post-injection.
Blood Collection for Pharmacokinectics:
Pre-injection, 4h ± 0.5h and 6 days ± 1 day post-injection.
OPTIONAL:
Blood collection at Day 4 ± 1 post-injection.
Part C:
IMAGING:
1 single injection of 89Zr-TLX300-CDx on Day 1 followed by whole-body imaging at 24h ± 4h, 4 days ± 1 post-injection and 7 days ± 1 day post-injection.
OPTIONAL:
Dynamic imaging 15 min ± 2 min post-injection at selected sites (extended field-of-view scanner available) and static imaging at 4h ± 0.5h post-injection.
Blood Collection for Pharmacokinectics:
Pre-injection, 4h ± 0.5h, 24h ± 4h, 4 days ± 1 day and 7 days ± 1 day post-injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Proof-of-concept tumour targeting of 89Zr-TLX300-CDx (Part A), assessment of 89Zr-TLX300-CDx biodistribution and tumour uptake (Part B) and radiation dosimetry (Part C).
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)One Injection of 89Zr-TLX300-CDx |
| Part B | Experimental | Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)One Injection of 89Zr-TLX300-CDx |
| Part C | Experimental | Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)One Injection of 89Zr-TLX300-CDx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥18 years of age at the time of signing the informed consent.
- 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.
- 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.
- 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).
Key exclusion criteria (9 listed)
- Known or suspected hypersensitivity to olaratumab, DFOsq, 89Zr or any of the excipients.
- IgE antibodies against galactose-α-1,3-galactose (α-Gal) above the ULN, >0.7 kU/L.
- Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX300-CDx.
- 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.
- Exposure to any radiopharmaceutical within 10 half-lives prior to the administration of 89Zr-TLX300-CDx.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)Single administration of 89Zr-TLX300-CDx | Drug | Part A, Part B, Part C |
Primary outcome
Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx
Time frame: 30 days
Number of Adverse events (AEs)
Biodistribution of 89Zr-TLX300-CDx
Time frame: 6 days
Measurement of absorbed radiation doses to organs.
Radiation dosimetry of 89Zr-TLX300-CDx
Time frame: 6 days
Measurement of absorbed radiation doses to tumour(s) and whole body.
Pharmacokinetics (PK)
Time frame: 6 days
Measure the antibody concentration at each timepoint to determine a PK curve.
1 secondary outcome
Determine a suitable antibody mass for administration
Time frame: 6 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx) in people with Soft Tissue Sarcoma and PDGFR Alpha Positive Solid Tumours, run by Telix Pharmaceuticals (Innovations) Pty Ltd at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brenda Cerqueira, M.Sc (+61 83180090, brenda.cerqueira@telixpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.