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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06537596




Registration number
NCT06537596
Ethics application status
Date submitted
29/04/2024
Date registered
5/08/2024
Date last updated
19/12/2024

Titles & IDs
Public title
89Zr-olaratumab Dosimetry in Participants With Soft Tissue Sarcoma
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.
Secondary ID [1] 0 0
89Zr-TLX300-101
Universal Trial Number (UTN)
Trial acronym
ZOLAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft Tissue Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)

Experimental: Part A - One Injection of 89Zr-TLX300-CDx

Experimental: Part B - One Injection of 89Zr-TLX300-CDx

Experimental: Part C - One Injection of 89Zr-TLX300-CDx


Treatment: Drugs: 89Zr-DFOsq-olaratumab (89Zr-TLX300-CDx)
Single administration of 89Zr-TLX300-CDx
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate clinical safety and tolerability of 89Zr-TLX300-CDx
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Biodistribution of 89Zr-TLX300-CDx
Timepoint [2] 0 0
6 days
Primary outcome [3] 0 0
Radiation dosimetry of 89Zr-TLX300-CDx
Timepoint [3] 0 0
6 days
Primary outcome [4] 0 0
Pharmacokinetics (PK)
Timepoint [4] 0 0
6 days
Secondary outcome [1] 0 0
Determine a suitable antibody mass for administration
Timepoint [1] 0 0
6 days

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

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 PDGFRa 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 PDGFRa 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 CRITERIA:

1. Known or suspected hypersensitivity to olaratumab, DFOsq, 89Zr or any of the excipients.
2. IgE antibodies against galactose-a-1,3-galactose (a-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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Precision Molecular Imaging & Theranostics Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3051 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Telix Pharmaceuticals (Innovations) Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Brenda Cerqueira, M.Sc
Address 0 0
Country 0 0
Phone 0 0
+61 83180090
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06537596