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New treatment option for Neoplastic Disease
Official title 131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)
ClinicalTrials.gov ID: NCT05450744
What this study is testing
What is 131I-IPA?
131I-IPA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoplastic disease.
Also referred to as 18F-FET.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Understand and voluntarily sign the informed consent form prior to any study related procedure and/or assessments being conducted.
- Are Male or Female, and aged 18 years or older, at the time of signing the informed consent.
- Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the...
- Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM.
- Have a Karnofsky Performance Status ≥70.
You likely can't join if
- Are unable to provide signed informed consent
- Have had prior treatment for glioma, excluding surgery.
- Are unable to undergo contrast-enhanced MRI.
- Intend to be treated with tumor-treating fields prior to progression.
- Have a history or evidence of delayed-type hypersensitivity (DTH)-dependent chronic infection (e.g., tuberculosis, systemic fungal or parasitic...
- Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
See the full eligibility criteria
- Understand and voluntarily sign the informed consent form prior to any study related procedure and/or assessments being conducted.
- Are Male or Female, and aged 18 years or older, at the time of signing the informed consent.
- Have histologically confirmed intracranial glioblastoma (per WHO 2021 definition) following surgical resection. Tumours primarily localised in the infratentorial compartment will be excluded.
- Have had prior surgery for glioblastoma, but no systemic therapy or radiation therapy for GBM.
- Have a Karnofsky Performance Status ≥70.
- Plan to begin chemoradiation therapy 3-6 weeks after surgical resection with Stupp regimen.
- 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...
- 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).
- 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)...
- Agree to practice adequate precautions to prevent pregnancy to avoid potential problems associated with radiation exposure to the unborn child.
- Females must have a negative pregnancy test at screening and on dosing day, must not be lactating.
- Are unable to provide signed informed consent
- Have had prior treatment for glioma, excluding surgery.
- Are unable to undergo contrast-enhanced MRI.
- Intend to be treated with tumor-treating fields prior to progression.
- 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.
- Have a known history of allergy TMZ, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
- Have haemostaseologic conditions, precluding catheterisation or invasive procedures.
- Have had phenylketonuria diagnosis previously
- Have any medical condition that in the opinion of the Investigator may interfere with the participant's ability to adhere to the study or may impose a risk to the participant's health.
- Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 3 weeks of administration of study treatment except surgery on primary tumour.
- Pregnant, breastfeeding or planning to get pregnant during the duration of the study.
- 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...
- 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...
- Have concurrent malignancies unless the patient has been disease-free without intervention for at least 2 years.
- Have taken growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
- Have serious, non-healing wound, ulcer, or bone fracture.
- Have a requirement of concurrent use of other anti-cancer treatments or agents other than study medication.
- Have received any other IMP within 90 days prior to the planned administration of study drug.
- Have uncontrolled Hashimoto's or Grave's disease
- Have on-going and unresolved Grade ≥ 1 AEs following surgical resection
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Gold Coast, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Linz, Austria
- Utrecht, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Gold Coast, Queensland, Australia; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia; Linz, Austria; Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.