InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 1 March 2024

IPAX-2: This phase I study is seeking to evaluate the safety of increasing radioactive dose levels of 131I-TLX101 when given in addition to best standard of care treatment in people with newly diagnosed glioblastomaA Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

Clinical summary

Summary

Eligible participants will receive 131I-TLX101, administered via intravenous infusion in ascending doses, as well as 18F-FET, also administered intravenously.

Conditions

This trial is treating patients with glioblastoma

Cancer

Brain and Spinal Cancers Brain and Spinal

Age

People18 - 65

Phase

I

Trial Acronym

IPAX-2

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Telix International Pty Ltd

Scientific Title

A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma

Eligibility

Inclusion

  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.

Exclusion

  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

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.