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

ConditionsNeoplastic Disease Glioblastoma Glioblastoma (GBM)Glioblastoma Multiform Glioblastoma Multiforme, Adult Glioblastoma Multiforme (GBM) WHO Grade IV

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorTelix Pharmaceuticals (Innovations) Pty Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.

Any systemic antineoplastic treatment other than nitroureas

Tumor-treating fields

Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy

Disqualifiers

Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.

Treatment with bevacizumab within the prior 6 weeks.

Known contraindication to imaging tracer or any product of contrast media and MRI contraindications including implanted medical devices. Unable to lie still for at least 20 min or the duration of the MRI and PET imaging or the need for general anesthesia as part of the imaging procedure.

History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).

Trial design

Design model

Sequential

Treatments tested in this trial

TLX-101-Tx + Lomustine
Combination product
Combination therapy with TLX-101-Tx + Lomustine
TLX101-Tx
Radiation
TLX101-Tx

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: TLX101-Tx + Standard of CareExperimental treatment 1 intervention

Group B: TLX101-Tx OnlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Safety and Tolerability

Assessing TEAEs type according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE V5.0.

Time frame

Through study completion, an average of 2 years

Dose Optimization

Part 1 of the study is being done to identify the best dose to use for Part 2 of the study

Time frame

Through study completion, an average of 2 years

Secondary outcomes

TLX101-Tx Concentration in the blood

Monitor how TLX101-Tx and its radioactive component move through the body over time. This includes checking how much of it is found in the blood at different times.

Time frame

From enrollment to the end of treatment at around 12 weeks.

Radiation Dosimetry

We will measure how much radiation from TLX101-Tx reaches the tumor and the bone marrow. This is done using special imaging scans (called SPECT, CT, and MRI) that help us see where the treatment goes in the body.

Time frame

Through study completion, an average of 2 years

TLX101-Tx Concentration in the Urine

Monitor how TLX101-Tx and its radioactive component move through the body over time. This includes checking how much is passed out in urine at different times following treatment.

Time frame

From enrollment to the end of treatment at around 12 weeks.