Actively Recruiting
131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2026-01-21
12
Participants Needed
6
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 consent
- Histologically confirmed intracranial glioblastoma (per WHO 2021) after surgical resection; exclude tumors primarily in infratentorial compartment
- Prior surgery for glioblastoma but no systemic or radiation therapy for GBM
- Karnofsky Performance Status of 70 or higher
- Plan to start chemoradiation therapy (Stupp regimen) 3-6 weeks after surgery
- Adequate organ function at screening including bone marrow, liver, and renal function within specified limits
- Availability of at least 6 unstained slides or a tissue block from biopsy or surgery
- Ability and willingness to comply with protocol and radiation protection guidelines
- Agree to use adequate pregnancy prevention methods
- Female participants must have negative pregnancy tests at screening and dosing and must not be breastfeeding
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 before disease progression
- History or evidence of chronic infections that may worsen with steroids
- Known allergy to temozolomide (TMZ), study medication components, or similar proteins/antibodies
- Bleeding disorders preventing catheterization or invasive procedures
- Previous diagnosis of phenylketonuria
- Any condition that may affect study adherence or participant safety
- Major trauma or major surgery (other than tumor surgery) within 3 weeks before study treatment
- Pregnant, breastfeeding, or planning pregnancy during the study
- Need for chronic high-dose corticosteroids or immunosuppressants (occasional corticosteroids allowed)
- Active uncontrolled infections or severe diseases posing risk or limiting compliance
- Concurrent cancers unless disease-free for at least 2 years
- Use of growth factors or immunomodulatory agents within 7 days before study treatment
- Serious non-healing wounds, ulcers, or bone fractures
- Concurrent use of other anti-cancer treatments besides study medication
- Received any investigational medicinal product within 90 days before study drug
- Uncontrolled Hashimoto's or Grave's disease
- Ongoing unresolved Grade 1 or higher adverse events from surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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