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TLX101

Phase 3

Neoplastic Disease | Small molecule | Oncology |Telix Pharmaceuticals Limited|Last Updated: Aug 11, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment50

FDA Designations

ORPHAN_DRUGFAST_TRACK

Clinical trial landscape

TLX101 · 1 trial · 6 indications

Phase 3 1
NCT07100730Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent GlioblastomaNeoplastic Disease
RECRUITING50 Analytics
PHASE3RECRUITING
Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma
Neoplastic Disease
NCT0710073050
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Study Endpoints

Primary Endpoints

Safety and Tolerability
Through study completion, an average of 2 years

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.

Dose Optimization
Through study completion, an average of 2 years

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

Secondary Endpoints

TLX101-Tx Concentration in the blood
From enrollment to the end of treatment at around 12 weeks.
Radiation Dosimetry
Through study completion, an average of 2 years
TLX101-Tx Concentration in the Urine
From enrollment to the end of treatment at around 12 weeks.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TLX101-Tx + Standard of CareEXPERIMENTALTLX101-Tx + Lomustine
TLX101-Tx OnlyEXPERIMENTALTLX101-Tx Therapy only

Interventions

NameTypeDescription
TLX-101-Tx + LomustineCOMBINATION_PRODUCTCombination therapy with TLX-101-Tx + Lomustine
TLX101-TxRADIATIONTLX101-Tx
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification. 2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal s...

Countries:AustraliaAustriaBelgiumNetherlands
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Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT07100730lastUpdatePostDate: changed
LOWAug 11, 2026NCT07100730lastUpdatePostDate: changed