Actively Recruiting
A Phase 1 Safety and Dose Finding Study of 131I-TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2026-01-21
12
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and appropriate dose of increasing levels of the radioactive drug 131I-TLX101, given by intravenous infusion, combined with the best standard care in adults newly diagnosed with glioblastoma, a type of brain cancer. This open-label, single-arm study is conducted across multiple centers and aims to understand how patients tolerate this treatment alongside standard therapies. Participants receive escalating doses of 131I-TLX101 through an intravenous infusion along with the standard chemoradiation therapy known as the Stupp regimen, beginning 3 to 6 weeks after surgical removal of the tumor. The study includes a dose-finding phase to establish the recommended dose, with safety monitored throughout. The radioactive drug is administered in ascending doses, and the study observes participants for up to 62 weeks. During the study, participants will undergo regular safety assessments including laboratory tests of liver and kidney function, monitoring for adverse events, and evaluations of treatment-related toxicities for up to 62 weeks. Researchers will track the incidence and severity of dose-limiting toxicities and treatment-emergent adverse events. Participants must comply with radiation safety guidelines and attend scheduled visits for monitoring. The total study duration from screening until the end is about 62 weeks.
CONDITIONS
Brief Title
131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form before any study procedures.
- Male or Female aged 18 years or older at the time of consent.
- Histologically confirmed intracranial glioblastoma following surgical resection, excluding tumors primarily in the infratentorial compartment.
- Prior surgery for glioblastoma with no prior chemotherapy or radiation therapy.
- Karnofsky Performance Status of 70 or higher.
- Planning to begin chemoradiation therapy 3 to 6 weeks after surgery with the Stupp regimen.
- Adequate organ function including bone marrow, liver, and renal function within specified limits.
- Availability of at least 6 unstained slides or a tissue block from prior biopsy or surgery.
- Ability to understand the study and comply with all protocol requirements including radiation safety.
- Agree to use adequate pregnancy prevention methods.
- Females must have a negative pregnancy test at screening and dosing, and must not be lactating.
You will not qualify if you...
- Unable to provide signed informed consent.
- Prior treatment for glioma other than surgery.
- Unable to undergo contrast-enhanced MRI.
- Plan to use tumor-treating fields prior to disease progression.
- History or evidence of delayed-type hypersensitivity-dependent chronic infections.
- Known allergy to temozolomide, excipients in the study drug, or other intravenously administered proteins.
- Bleeding or clotting disorders preventing catheterization or invasive procedures.
- Previous diagnosis of phenylketonuria.
- Any medical condition that may interfere with study adherence or pose health risks.
- Major surgery within 3 weeks before study treatment except primary tumor surgery.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Requirement for chronic high-dose corticosteroids or immunosuppressants.
- Active uncontrolled infections or severe concurrent diseases.
- Concurrent malignancies unless disease-free for at least 2 years.
- Use of growth factors or immunomodulatory agents within 7 days before study drug.
- Serious non-healing wounds, ulcers, or bone fractures.
- Concurrent use of other anti-cancer treatments besides study medication.
- Received any other investigational product within 90 days before study drug.
- Uncontrolled Hashimoto's or Grave's disease.
- Ongoing unresolved grade 1 or higher adverse events after surgery surgery.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 62 weeks
Participants receive the investigational drug 131I-TLX101 in ascending doses alongside standard chemoradiation therapy according to the Stupp regimen.
Multiple visits for dosing and safety assessments during treatment
Trial Site Locations
Total: 6 locations
1
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Actively Recruiting
2
Gold Coast University Hospital
Gold Coast, Queensland, Australia, 4215
Actively Recruiting
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Actively Recruiting
4
Olivia Newton John Cancer Research Institute/Austin Health
Melbourne, Victoria, Australia
Actively Recruiting
5
Institut für Nuklearmedizin und Endokrinologie
Linz, Austria
Actively Recruiting
6
UNMC Utrecht
Utrecht, Netherlands, 3051
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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