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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07100730




Registration number
NCT07100730
Ethics application status
Date submitted
17/07/2025
Date registered
3/08/2025
Date last updated
3/08/2025

Titles & IDs
Public title
Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma
Scientific title
A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])
Secondary ID [1] 0 0
2025-521785-10
Secondary ID [2] 0 0
131I-TLX-101-003
Universal Trial Number (UTN)
Trial acronym
IPAX BrIGHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplastic Disease 0 0
Glioblastoma 0 0
Glioblastoma (GBM) 0 0
Glioblastoma Multiform 0 0
Glioblastoma Multiforme, Adult 0 0
Glioblastoma Multiforme (GBM) WHO Grade IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Any cancer
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - TLX-101-Tx + Lomustine
Treatment: Other - TLX101-Tx

Experimental: TLX101-Tx + Standard of Care - TLX101-Tx + Lomustine

Experimental: TLX101-Tx Only - TLX101-Tx Therapy only


Other interventions: TLX-101-Tx + Lomustine
Combination therapy with TLX-101-Tx + Lomustine

Treatment: Other: TLX101-Tx
TLX101-Tx
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability
Timepoint [1] 0 0
Through study completion, an average of 2 years
Primary outcome [2] 0 0
Dose Optimization
Timepoint [2] 0 0
Through study completion, an average of 2 years
Secondary outcome [1] 0 0
TLX101-Tx Concentration in the blood
Timepoint [1] 0 0
From enrollment to the end of treatment at around 12 weeks.
Secondary outcome [2] 0 0
Radiation Dosimetry
Timepoint [2] 0 0
Through study completion, an average of 2 years
Secondary outcome [3] 0 0
TLX101-Tx Concentration in the Urine
Timepoint [3] 0 0
From enrollment to the end of treatment at around 12 weeks.

Eligibility
Key inclusion criteria
1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.
2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy having occurred at least 3 months after the end of prior radiotherapy. Prior first-line therapy may include a combination of:

1. Any systemic antineoplastic treatment other than nitroureas
2. Tumor-treating fields
3. Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy
3. Increased [18F]]FET PET tracer uptake inside or in the vicinity of tumor. Specifically, amino acid-based molecular imaging using [18F]FET PET will be evaluated following co-registration with MRI. The allocated physician/reader will assess whether the observed pathologically increased amino acid uptake is located within the tumor or in the vicinity. This determination will serve as a guidance to confirm whether the uptake is tumor-associated. The uptake must be clearly discernible from background activity and measurable per PET RANO 1.0 criteria, as determined by central review.
4. Tumor debulking for recurrent, progressive disease is allowed. The patient must have post-surgical (4-6 weeks) radiographic evidence for residual tumor according to RANO 2.0 with increased [18F] FET PET uptake and measurable disease according to PET RANO 1.0.
5. 18 years or older
6. Have the capacity to understand the study and be willing to comply with all protocol requirements.
7. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 or KPS=70
8. Patients on stable, not increasing dose of steroids in the previous 7 days can be included in the study
9. Adequate hematological, liver and renal function at the time of screening.
10. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of investigational drug product; must not be breast-feeding; and must agree to use a highly effective method of contraception during treatment and for 6 months following last dose of investigational product.
11. Male patients must agree to use condoms during sex during the treatment period and for 3 months after the last dose of the investigational drug product and must not make semen donations during treatment and for 6 months following last dose of investigational drug product. For male patients with female partners of childbearing potential, females must agree to use a highly effective method of contraception during the treatment period and for 6 months following last dose of investigational drug product.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.
2. Treatment with bevacizumab within the prior 6 weeks.
3. Known contraindication to imaging tracer or any product of contrast media and MRI contraindications including implanted medical devices. Unable to lie still for at least 20 min or the duration of the MRI and PET imaging or the need for general anesthesia as part of the imaging procedure.
4. History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).
5. Radiographic progression based on RANO 2.0 associated with clinical deterioration and life expectancy less than 3 months.
6. Hemostaseologic conditions, precluding catheterization or invasive procedures.
7. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
8. Known liver or kidney disease, such as hepatitis, cirrhosis, renal failure.
9. Severe chronic or active infections (including active tuberculosis, hepatitis B virus, or hepatitis C virus infection) requiring systemic therapy.
10. Ongoing toxicity > Grade 2 NCI-CTCAE (version 5.0) from previous standard or investigational therapies.
11. Administration of another investigational product within 90 days prior to screening.
12. Expected non-compliance with longer-term admission at isolated nuclear medicine ward per regional regulations.
13. Inability to complete the needed investigational and standard imaging examinations due to any reason (ie, severe claustrophobia, inability to lie still for the entire imaging time).
14. Patients with known phenylketonuria.
15. Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study investigator, would make the patient inappropriate for entry into the study.

Study design
Purpose of the study
Treatment
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
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Gold Coast
Recruitment postcode(s) [1] 0 0
- Gold Coast

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
Clinical Project Manager
Address 0 0
Country 0 0
Phone 0 0
2154902000
Fax 0 0
Email 0 0
[email protected]
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
We have opted not to share individual participant data due to concerns regarding participant privacy and the absence of explicit consent for data sharing in the original trial protocol especially for patients enrolled in the EU.


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/NCT07100730