Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

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.

Trial Details

NCT ID
NCT07100730
Phase
PHASE3
Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • TLX-101-Tx + Lomustine
  • TLX101-Tx
Locations (sample)
  • Gold Coast, Queensland, Australia|-28.00029,153.43088
  • Melbourne, Australia|-37.814,144.96332
  • Linz, Austria|48.30639,14.28611
  • Utrecht, Netherlands|52.09083,5.12222

Key Eligibility Criteria

  • Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.
  • Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maxi…
  • Any systemic antineoplastic treatment other than nitroureas
  • Tumor-treating fields

For full eligibility, visit ClinicalTrials.gov.

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