Neoplastic DiseasePhase 3IPAX BrIGHTNCT07100730
Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma
A Phase 3 study testing TLX-101-Tx + Lomustine and TLX101-Tx in people with Neoplastic Disease and Glioblastoma, run by Telix Pharmaceuticals (Innovations) Pty Limited at 9 sites in 4 countries.
Trial summary
This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplastic Disease, Glioblastoma, Glioblastoma (GBM)
- What is being tested?
- TLX-101-Tx + Lomustine and TLX101-Tx
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 2 Nov 2025to Nov 2027
- Phase
- Phase 3
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
- Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.
- 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:
- Any systemic antineoplastic treatment other than nitroureas
- Tumor-treating fields
- Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy
- 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.
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- 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.
- 18 years or older
- Have the capacity to understand the study and be willing to comply with all protocol requirements.
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 or KPS≥70
- Patients on stable, not increasing dose of steroids in the previous 7 days can be included in the study
- Adequate hematological, liver and renal function at the time of screening.
- 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.
- 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.
Who cannot join
- Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.
- Treatment with bevacizumab within the prior 6 weeks.
- 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.
- History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).
- Radiographic progression based on RANO 2.0 associated with clinical deterioration and life expectancy less than 3 months.
- Hemostaseologic conditions, precluding catheterization or invasive procedures.
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- Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.
- Known liver or kidney disease, such as hepatitis, cirrhosis, renal failure.
- Severe chronic or active infections (including active tuberculosis, hepatitis B virus, or hepatitis C virus infection) requiring systemic therapy.
- Ongoing toxicity > Grade 2 NCI-CTCAE (version 5.0) from previous standard or investigational therapies.
- Administration of another investigational product within 90 days prior to screening.
- Expected non-compliance with longer-term admission at isolated nuclear medicine ward per regional regulations.
- 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).
- Patients with known phenylketonuria.
- 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.
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Back-up Clinical Project Manager contact
9 sites in 4 countries
Australia4 sites, 4 recruiting
- Not yet recruiting
Royal Adelaide Hospital
Adelaide
Study Coordinator, Kelly.Dang@sa.gov.au
Back-up study coordinator, Olivia.Franze@sa.gov.au
- Recruiting
Gold Coast University Hospital
Gold Coast, Queensland
Clinical Trials Coordinator, 07 568 70664, GCHClinicalTrialServices@health.qld.gov.au
- Recruiting
Austin Health
Melbourne, Victoria
Study Coordinator, (03) 94963088, Samantha.chakar@austin.org.au
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia
Study Coordinator, SCGH.MOCTUPodC@health.wa.gov.au
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven
Leuven
- Recruiting
Chu of Liège
Liège
Netherlands2 sites, 2 recruiting
- Not yet recruiting
The Netherlands Cancer Institute (NKI)
Amsterdam
- Recruiting
UMC Utrecht
Utrecht
About this study
Official 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])
This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.
- Conditions
- Neoplastic Disease, Glioblastoma, Glioblastoma (GBM), Glioblastoma Multiform, Glioblastoma Multiforme, Adult, Glioblastoma Multiforme (GBM) WHO Grade IV
- Being tested
- TLX-101-Tx + Lomustine, TLX101-Tx
- Keywords
- Lomustine, Radiation Therapy, Radiopharmaceuticals, Positron-Emission Tomography, Brain Neoplasms, Glioblastoma Multiforme, Glioblastoma, GBM, Neoplasm Recurrence, Local, Central Nervous System Neoplasms, Brain cancer, Recurrent brain tumor, Brain tumor recurrence, LAT-1 targeted therapy
- Medical subject headings
- Neoplasms, Glioblastoma, Brain Neoplasms, Neoplasm Recurrence, Local, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLX-101-Tx + LomustineCombination product
Also called 131I-IPA, 131I-TLX101
Combination therapy with TLX-101-Tx + Lomustine
TLX101-TxRadiation
Also called 131I-IPA, 131I-TLX101
TLX101-Tx
| Study group | Role | What they receive |
|---|---|---|
| TLX101-Tx + Standard of Care | Experimental | TLX101-Tx + Lomustine Receives: Combination Product: TLX-101-Tx + Lomustine |
| TLX101-Tx Only | Experimental | TLX101-Tx Therapy only Receives: Radiation: TLX101-Tx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Assessing TEAEs type according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE V5.0.
Measured: Through study completion, an average of 2 years
Dose Optimization
Part 1 of the study is being done to identify the best dose to use for Part 2 of the study
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
TLX101-Tx Concentration in the blood
Monitor how TLX101-Tx and its radioactive component move through the body over time. This includes checking how much of it is found in the blood at different times.
Measured: From enrollment to the end of treatment at around 12 weeks.
Radiation Dosimetry
We will measure how much radiation from TLX101-Tx reaches the tumor and the bone marrow. This is done using special imaging scans (called SPECT, CT, and MRI) that help us see where the treatment goes in the body.
Measured: Through study completion, an average of 2 years
TLX101-Tx Concentration in the Urine
Monitor how TLX101-Tx and its radioactive component move through the body over time. This includes checking how much is passed out in urine at different times following treatment.
Measured: From enrollment to the end of treatment at around 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start2 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In the first part of the trial, cohort of patients will receive different doses of the study drug and lomustine. If the drug is not well tolerated, the dose will change in new groups of patients and additional arms of the study will open. Doctors watch closely for any serious side effects, which helps them decide when the dose is too high.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100730
- Sponsor's protocol ID
- 131I-TLX-101-003
- Other IDs
- 2025-521785-10, 2025
- Acronym
- IPAX BrIGHT
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.