Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
131I-IPA · 1 trial · 3 indications
Incidence rate and the grade (severity) of DLTs based on the occurrence of Adverse Events (AEs) reported according to the NCI CTCAE v6.0. DLTs include any grade ≥ 3 events considered possibly related to the study drug, but excludes cerebral oedema, and haematological toxicity.
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.
| Arm | Type | Description |
|---|---|---|
| 131I-TLX101 + standard of care | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 131I-IPA | DRUG | 131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously |
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 years or older, at the time of signing the informed consent. 3. Have histologically confirmed intracranial gli...
131I-IPA is an investigational small molecule being developed for the treatment of neoplastic disease, specifically glioblastoma, including glioblastoma multiforme. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
131I-IPA targets the LAT1 transporter, which is a molecular target involved in amino acid transport. By targeting LAT1, the drug is designed to deliver a radioactive iodine isotope (131I) to cancer cells, potentially enabling targeted radiation therapy for tumors.
131I-IPA is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glioblastoma.
131I-IPA is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety, tolerability, and potential efficacy in treating neoplastic diseases such as glioblastoma.
131I-IPA is being evaluated in a Phase 1 clinical trial with the identifier NCT05450744, titled '131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)'. This trial is active but not recruiting, with an enrollment of 12 participants across Australia, Austria, and the Netherlands.
Yes, 131I-IPA is also known as 131I-TLX-101. The clinical trial NCT05450744 uses the name 131I-TLX-101 to refer to the same investigational drug, which is being studied for the treatment of newly diagnosed glioblastoma.