89Zr-olaratumab Dosimetry in Participants With PDGFR Alpha Positive Solid Tumours and Soft Tissue Sarcoma (ZOLAR)

August 12, 2026 updated by: Telix Pharmaceuticals (Innovations) Pty Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • Queensland
    • Victoria
      • Melbourne, Victoria, Australia, 3051
        • Recruiting
        • Precision Molecular Imaging & Theranostics Pty Ltd
        • Principal Investigator:
          • Rodney Hicks, Prof.
        • Contact:
        • Contact:
    • Western Australia
      • Perth, Western Australia, Australia, 6150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A
One Injection of 89Zr-TLX300-CDx
Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Single administration of 89Zr-TLX300-CDx
Experimental: Part B
One Injection of 89Zr-TLX300-CDx
Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Single administration of 89Zr-TLX300-CDx
Experimental: Part C
One Injection of 89Zr-TLX300-CDx
Drug: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Single administration of 89Zr-TLX300-CDx

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx
Time Frame: 30 days
Number of Adverse events (AEs)
30 days
Pharmacokinetics (PK)
Time Frame: 6 days
Measure the antibody concentration at each timepoint to determine a PK curve.
6 days
Biodistribution of 89Zr-TLX300-CDx
Time Frame: 6 days
Measurement of absorbed radiation doses to organs.
6 days
Radiation dosimetry of 89Zr-TLX300-CDx
Time Frame: 6 days
Measurement of absorbed radiation doses to tumour(s) and whole body.
6 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine a suitable antibody mass for administration
Time Frame: 6 days
SUV values of tumour lesions and tumour to background organ (e.g. blood/liver/muscle) ratios.
6 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare the tumour uptake and detection of lesions between 89Zr-TLX300-CDx and standard of care imaging
Time Frame: 30 days
89Zr-TLX300-CDx uptake within tumours and organs and Localisation of tumour deposits on conventional imaging (CT, MRI and/or FDGPET)
30 days
Evaluate the correlation between tumour uptake of 89Zr-TLX300-CDx and PDGFRα expression
Time Frame: 30 days
Immunohistochemistry expression of PDGFRα in tumour tissue AND SUV tumour values and tumour to background ratios.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Telix Pharmaceuticals (Innovations) Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 89Zr-TLX300-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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