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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100730 on ClinicalTrials.gov