Actively Recruiting
Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma
Led by Telix Pharmaceuticals (Innovations) Pty Limited · Updated on 2026-04-16
50
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.
CONDITIONS
Official Title
Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype, per WHO 2021 classification
- Radiographic evidence of first recurrence or progression after first-line treatment including biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy at least 3 months prior
- Increased [18F]FET PET tracer uptake inside or near tumor measurable per PET RANO 1.0 criteria
- Post-surgical radiographic evidence of residual tumor with increased [18F]FET PET uptake and measurable disease if tumor debulking was done
- Age 18 years or older
- Ability to understand the study and comply with protocol
- ECOG Performance Status of 0 to 2 or Karnofsky Performance Status ≥70
- Stable steroid dose with no increase in previous 7 days
- Adequate blood, liver, and kidney function at screening
- Females of childbearing potential must have negative pregnancy test within 7 days before first dose, not breastfeeding, and agree to effective contraception during treatment and 6 months after
- Male patients must agree to condom use during treatment and 3 months after last dose, avoid semen donation during treatment and 6 months after, and female partners must use effective contraception during treatment and 6 months after
You will not qualify if you...
- Brain external beam radiation therapy within past 3 months or prior brain brachytherapy
- Bevacizumab treatment within prior 6 weeks
- Contraindications to imaging tracer, contrast agents, MRI, or inability to lie still for imaging
- History or evidence of delayed-type hypersensitivity infections like tuberculosis or systemic fungal/parasitic infections
- Radiographic progression with clinical deterioration and life expectancy under 3 months
- Bleeding disorders preventing catheterization or invasive procedures
- Significant illness or trauma within 2 weeks before investigational product administration
- Known liver or kidney disease such as hepatitis, cirrhosis, or renal failure
- Severe chronic or active infections requiring systemic therapy
- Ongoing toxicity greater than Grade 2 from prior therapies
- Use of another investigational product within 90 days prior to screening
- Expected inability to comply with nuclear medicine ward admission regulations
- Inability to complete required imaging due to claustrophobia or other reasons
- Known phenylketonuria
- Any condition increasing risk or interfering with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Gold Coast University Hospital
Gold Coast, Queensland, Australia
Actively Recruiting
2
Austin Health
Melbourne, Australia
Actively Recruiting
3
Johannes Kepler University
Linz, Austria
Actively Recruiting
4
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
C
Clinical Project Manager
CONTACT
B
Back-up Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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