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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05450744




Registration number
NCT05450744
Ethics application status
Date submitted
22/04/2022
Date registered
11/07/2022

Titles & IDs
Public title
131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)
Scientific title
A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma
Secondary ID [1] 0 0
131I-TLX-101-002 (IPAX-2)
Universal Trial Number (UTN)
Trial acronym
IPAX-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplastic Disease 0 0
Glioblastoma 0 0
Glioblastoma Multiforme 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 131I-IPA

Experimental: 131I-TLX101 + standard of care -


Treatment: Drugs: 131I-IPA
131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate and the grade (severity) of DLTs
Timepoint [1] 0 0
8 weeks from the first dose of IMP until discharge from the second dosem, up to 62 weeks.
Primary outcome [2] 0 0
Safety, tolerability and RP2D
Timepoint [2] 0 0
From screening until end of study, assessed over 62 weeks. TEAEs - units are frequency (percentage) and severity. Laboratory - safety laboratory including liver functions test, report mean and out of range.

Eligibility
Key inclusion criteria
1. Understand and voluntarily sign the informed consent form prior to any study related procedure and/or assessments being conducted.
2. Are Male or Female, and aged 18-65 years of age inclusive, at the time of signing the informed consent.
3. Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the infratentorial compartment will be excluded.
4. Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM.
5. Have a Karnofsky Performance Status =70.
6. Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen.
7. Have adequate organ function at Screening:

7.1 Bone marrow: 7.1.1 Leukocytes =3,000/mL 7.1.2 Absolute neutrophil count =1500/mL 7.1.3 Platelets =100,000/mL 7.1.4 Haemoglobin =9g/dL 7.2 Liver function: 7.2.1 Total bilirubin =1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome =3×ULN is permitted 7.2.2 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2.5×ULN 7.3 Renal function: 7.3.1 Serum/plasma creatinine =1.5×ULN or creatinine clearance =50 mL/min
8. Have at least 6 slides without staining or a tissue block (frozen or paraffin-embedded) available from a previous biopsy or surgery (tumour sample previously archived).
9. Have the capacity to understand the study and be able and willing to comply with all protocol requirements, including compliance with the radiation protection guidelines (including hospital admissions and isolation) that are applied by the treating institution to protect their contacts and the public.
10. Agree to practice adequate precautions to prevent pregnancy to avoid potential problems associated with radiation exposure to the unborn child.
11. Females must have a negative pregnancy test at screening and on dosing day, must not be lactating.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Are unable to provide signed informed consent
2. Have had prior treatment for glioma, excluding surgery.
3. Are unable to undergo contrast-enhanced MRI.
4. Intend to be treated with tumor-treating fields prior to progression.
5. Have a history or evidence of delayed-type hypersensitivity (DTH)-dependent chronic infection (e.g., tuberculosis, systemic fungal or parasitic infection), potentially exacerbating under systemic corticoid therapy.
6. Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
7. Have haemostaseologic conditions, precluding catheterisation or invasive procedures.
8. Have phenylketonuria
9. Have a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g., risk of doing harm to self or others), or patients with active severe personality disorders.
10. Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 3 weeks of administration of study treatment except surgery on primary tumour.
11. Pregnant, breastfeeding or planning to get pregnant during the duration of the study.
12. Requirement of chronic administration of high dose corticosteroids or other immunosuppressant drugs. Limited or occasional use of corticosteroids to treat or prevent acute adverse reactions is not considered an exclusion criterion.
13. Have presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the participant at undue risk or unable to comply with study requirements. HIV-positive participants may be included in the study if they are on a stable dose of anti-retroviral therapy.
14. Have concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years.
15. Have taken growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
16. Have serious, non-healing wound, ulcer, or bone fracture.
17. Have a requirement of concurrent use of other anti-cancer treatments or agents other than study medication.
18. Have received any other IMP within 90 days prior to the planned administration of study drug.
19. Have uncontrolled Hashimoto's or Grave's disease
20. Have on-going and unresolved Grade = 1 AEs following surgical resection

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Other
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
1/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Olivia Newton John Cancer Research Institute/Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Gold Coast
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Netherlands
State/province [2] 0 0
Utrecht
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Telix Pharmaceuticals (Innovations) Pty Limited
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT05450744