Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma
NCT07100730 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-16
Summary
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
- Neoplastic Disease
- Glioblastoma
- Glioblastoma (GBM)
- Glioblastoma Multiform
- Glioblastoma Multiforme, Adult
- Glioblastoma Multiforme (GBM) WHO Grade IV
Interventions
- COMBINATION_PRODUCT
-
TLX-101-Tx + Lomustine
Combination therapy with TLX-101-Tx + Lomustine
- RADIATION
-
TLX101-Tx
TLX101-Tx
Sponsors & Collaborators
-
Telix Pharmaceuticals (Innovations) Pty Limited
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-02
- Primary Completion
- 2027-07-31
- Completion
- 2027-11-30
Countries
- Australia
- Austria
- Netherlands
Study Locations
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